New cancer drugs
New cancer approvals, screened before NIOSH gets to them
NIOSH updates its List of Hazardous Drugs every few years, so a newly approved cancer drug can go unassessed for a long time. Its package insert can be read the day it is published: every drug below is scored against the same six criteria, with the label language one click away. New uses of approved drugs are here too, from FDA's oncology approval notices.
2026 35 approvals
- Tecentriq atezolizumab
Programmed death-ligand 1 blocking antibodyThe adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient (dMMR) colon…
3/6Developmental / reproductive languageSee the label findings - Tukysa tucatinib
Kinase inhibitorThe maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction…
3/6Developmental / reproductive languageSee the label findings - Jaypirca pirtobrutinib
Kinase inhibitorAdult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no known 17p deletion
4/6Carcinogenic / genotoxic findings in the labelSee the label findings - Welireg belzutifan
Hypoxia-inducible factor inhibitorAdults with advanced renal cell carcinoma with a clear cell component (ccRCC) following a programmed death receptor-1 (PD-1) or programmed…
3/6Developmental / reproductive languageSee the label findings - Inluriyo imlunestrant
Estrogen receptor antagonistAdults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated…
4/6Carcinogenic / genotoxic findings in the labelSee the label findings - Hyrnuo sevabertinib
Kinase inhibitorAdult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine…
2/6Developmental / reproductive languageSee the label findings - Rasonque daraxonrasib
Inhibitor of the RAS GTPase familyAdult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for…
2/6Developmental / reproductive languageSee the label findings - Ziihera zanidatamab-hrii
Bispecific HER2-directed antibodyAdults with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or…
3/6Special-handling language in the labelSee the label findings - Zenbexus iberdomide
Cereblon-modulating protein degraderCombination with daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have…
5/6Special-handling language in the labelSee the label findings - Pluvicto lutetium Lu 177 vipivotide tetraxetan
Radioligand therapeutic agentAdults with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or-sensitive (mAPMN/S) prostate…
5/6Carcinogenic / genotoxic findings in the labelSee the label findings - Jideytro zidesamtinib
Kinase inhibitorAdult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase…
4/6Carcinogenic / genotoxic findings in the labelSee the label findings - Revtorpyk gedatolisib
Kinase inhibitorCombination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human…
2/6Developmental / reproductive languageSee the label findings - Retevmo selpercatinib
Kinase inhibitorAdult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected…
Screening…See the label findings - Keytruda pembrolizumab
Programmed death receptor-1-blocking antibodyAdults with muscle invasive bladder cancer (MIBC)
Screening…See the label findings - Sarclisa Escena isatuximab-irfc
CD38-directed cytolytic antibodySubcutaneous injection for multiple myeloma indications
Screening…See the label findings - Trodelvy sacituzumab govitecan-hziy
Trop-2-directed antibody and topoisomerase inhibitor conjugateTwo indications in adults with triple-negative breast cancer (TNBC)
Screening…See the label findings - Ibrance palbociclib
Kinase inhibitorThe maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction…
Screening…See the label findings - Truqap capivasertib
Kinase inhibitorAdults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic…
Screening…See the label findings - Welireg belzutifan
Hypoxia-inducible factor inhibitorThe adjuvant treatment of adults with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of…
3/6Developmental / reproductive languageSee the label findings - Imfinzi durvalumab
Programmed death-ligand 1 blocking antibodyAdult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC)
Screening…See the label findings - Decnupaz pivekimab sunirine-pvzy
CD123-directed antibody and alkylating agent conjugateAdult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN)
Screening…See the label findings - Datroway datopotamab deruxtecan-dlnk
Trop-2-directed antibody and topoisomerase inhibitor conjugateAdult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy
Screening…See the label findings - Tecentriq atezolizumab
Programmed death-ligand 1 blocking antibodyAdults with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD) as…
3/6Developmental / reproductive languageSee the label findings - Beqalzi sonrotoclax
BCL-2 inhibitorAdult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's…
Screening…See the label findings - Inqovi decitabine and cedazuridine
Nucleoside metabolic inhibitorNewly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude the use of intensive…
Screening…See the label findings - Bizengri zenocutuzumab-zbco
Bispecific HER2-and HER3-directed antibodyAdults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on…
Screening…See the label findings - Veppanu vepdegestrant
Heterobifunctional protein degraderAdults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1) -mutated…
Screening…See the label findings - Lifyorli relacorilant
Glucocorticoid receptor antagonistCombination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary…
Screening…See the label findings - Opdivo nivolumab
Programmed death receptor-1 blocking antibodyAdult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL)
Screening…See the label findings - Tecvayli teclistamab
Bispecific B-cell maturation antigen-directed CD3 T-cell engagerAdult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome…
Screening…See the label findings - Hernexeos zongertinib
Kinase inhibitorAn expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2…
Screening…See the label findings - Braftovi encorafenib
Kinase inhibitorAdult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-authorized test
Screening…See the label findings - Calquence acalabrutinib
Kinase inhibitorAdults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Screening…See the label findings - Keytruda pembrolizumab
Programmed death receptor-1-blocking antibodyAdult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1…
Screening…See the label findings - Darzalex Faspro daratumumab and hyaluronidase-fihj
Immunoglobulin G1 kappa human monoclonal antibodyAdults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT)
Screening…See the label findings
2025 49 approvals
- Rybrevant Faspro amivantamab and hyaluronidase-lpuj
Bispecific antibodySubcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab (Rybrevant, Janssen…
Screening…See the label findings - Rubraca rucaparib
Poly (ADP-ribose) polymerase inhibitorAdults with a deleterious BRCA mutation ( BRCA m) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer…
Screening…See the label findings - Enhertu fam-trastuzumab deruxtecan-nxki
HER2-directed antibody and topoisomerase inhibitor conjugateThe first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an…
Screening…See the label findings - Akeega niraparib and abiraterone acetate
Poly (ADP-ribose) polymerase inhibitorAdults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC), as…
Screening…See the label findings - Jaypirca pirtobrutinib
Kinase inhibitorAdults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated…
4/6Carcinogenic / genotoxic findings in the labelSee the label findings - Imfinzi durvalumab
Programmed death-ligand 1 blocking antibodyAdults with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC)
Screening…See the label findings - Keytruda pembrolizumab
Programmed death receptor-1-blocking antibodyAdults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin
Screening…See the label findings - Hyrnuo sevabertinib
Kinase inhibitorAdult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 ( ERBB2 ) tyrosine…
2/6Developmental / reproductive languageSee the label findings - Imdelltra tarlatamab-dlle
Bispecific delta-like ligand 3-directed CD3 T-cell engagerAdults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy
Screening…See the label findings - Darzalex Faspro daratumumab and hyaluronidase-fihj
Immunoglobulin G1 kappa human monoclonal antibodyNewly diagnosed light chain (AL) amyloidosis
Screening…See the label findings - Koselugo selumetinib
Kinase inhibitorAdults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN)
Screening…See the label findings - Epkinly epcoritamab-bysp
Bispecific CD20-directed CD3 T-cell engagerRelapsed or refractory follicular lymphoma (FL)
Screening…See the label findings - Komzifti ziftomenib
Menin inhibitorAdult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation who have no…
Screening…See the label findings - Darzalex Faspro daratumumab and hyaluronidase-fihj
Immunoglobulin G1 kappa human monoclonal antibodyAdults with high-risk smoldering multiple myeloma (SMM)
Screening…See the label findings - Revuforj revumenib
Menin inhibitorRelapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 ( NPM1 ) mutation in adult and pediatric patients 1 year…
Screening…See the label findings - Blenrep belantamab mafodotin-blmf
B-cell maturation antigen-directed antibody and microtubule inhibitor conjugateAdults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal…
Screening…See the label findings - Libtayo cemiplimab-rwlc
Programmed death receptor-1 blocking antibodyThe adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation
Screening…See the label findings - Zepzelca lurbinectedin
Alkylating drugThe maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after…
Screening…See the label findings - Inluriyo imlunestrant tosylate
Estrogen receptor antagonistAdults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 ( ESR1 )-mutated…
4/6Carcinogenic / genotoxic findings in the labelSee the label findings - Keytruda Qlex pembrolizumab and berahyaluronidase alfa-pmph
Programmed death receptor-1-blocking antibodySubcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of…
Screening…See the label findings - Koselugo selumetinib
Kinase inhibitorPediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN)
Screening…See the label findings - Inlexzo gemcitabine intravesical system
Nucleoside metabolic inhibitor-containing intravesical systemAdults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or…
Screening…See the label findings - Hernexeos zongertinib
Kinase inhibitorAdult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine…
Screening…See the label findings - Modeyso dordaviprone
Protease activatorAdult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease…
Screening…See the label findings - Lynozyfic linvoseltamab-gcpt
Bispecific B-cell maturation antigen‑directed CD3 T-cell engagerAdult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome…
Screening…See the label findings - Datroway datopotamab deruxtecan-dlnk
Trop-2-directed antibody and topoisomerase inhibitor conjugateAdults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have…
Screening…See the label findings - Monjuvi tafasitamab-cxix
CD19-directed cytolytic antibodyAdults with relapsed or refractory follicular lymphoma (FL)
Screening…See the label findings - Keytruda pembrolizumab
Programmed death receptor-1-blocking antibodyAdults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score…
Screening…See the label findings - Zusduri mitomycin intravesical solution
Alkylating drugAdult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)
Screening…See the label findings - Ibtrozi taletrectinib adipate
Kinase inhibitorAdult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) [see Dosage and Administration ( 2
Screening…See the label findings - Nubeqa darolutamide
Androgen receptor inhibitorMetastatic castration-sensitive prostate cancer (mCSPC)
Screening…See the label findings - Zynyz retifanlimab-dlwr
Programmed death receptor-1–blocking antibodyThe first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC)
Screening…See the label findings - Emrelis telisotuzumab vedotin
C-Met-directed antibody and microtubule inhibitor conjugateAdult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression…
Screening…See the label findings - Welireg belzutifan
Hypoxia-inducible factor inhibitorAdult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL)
3/6Developmental / reproductive languageSee the label findings - Avmapki Fakzynja CO-Pack avutometinib potassium and defactinib hydrochloride
Adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy
Screening…See the label findings - Penpulimab
Programmed death receptor-1-blocking antibodyThe first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC)
Screening…See the label findings - Opdivo nivolumab
Programmed death receptor-1 blocking antibodyThe first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC)
Screening…See the label findings - Opdivo nivolumab
Programmed death receptor-1 blocking antibodyAdult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch…
Screening…See the label findings - Imfinzi durvalumab
Programmed death-ligand 1 blocking antibodyAdults with muscle invasive bladder cancer (MIBC)
Screening…See the label findings - Pluvicto lutetium Lu 177 vipivotide tetraxetan
Radioligand therapeutic agent
5/6Carcinogenic / genotoxic findings in the labelSee the label findings - Cabometyx cabozantinib
Kinase inhibitorAdult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic…
Screening…See the label findings - Keytruda pembrolizumab
Programmed death receptor-1-blocking antibodyThe first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ)…
Screening…See the label findings - Romvimza vimseltinib
Kinase inhibitorAdult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening…
Screening…See the label findings - Adcetris brentuximab vedotin
CD30-directed antibody and microtubule inhibitor conjugateAdult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise…
Screening…See the label findings - Enhertu fam-trastuzumab deruxtecan-nxki
HER2-directed antibody and topoisomerase inhibitor conjugateUnresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining)…
Screening…See the label findings - Grafapex treosulfan
Alkylating drugCombination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients…
Screening…See the label findings - Datroway datopotamab deruxtecan
Trop-2-directed antibody and topoisomerase inhibitor conjugateAdult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who…
Screening…See the label findings - Lumakras sotorasib
Inhibitor of the RAS GTPase familyAdult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior…
Screening…See the label findings - Calquence acalabrutinib
Kinase inhibitorAdults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT)
Screening…See the label findings
2024 52 approvals
- Opdivo Qvantig nivolumab and hyaluronidase-nvhy
Programmed death receptor-1 blocking antibodySubcutaneous injection across approved adult, solid tumor nivolumab (Opdivo, Bristol Myers Squibb Company) indications as monotherapy…
Screening…See the label findings - Braftovi encorafenib
Kinase inhibitorPatients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test
Screening…See the label findings - Ensacove ensartinib
Kinase inhibitorAdult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)as detected…
Screening…See the label findings - Unloxcyt cosibelimab-ipdl
Programmed death ligand-1 blocking antibodyAdults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative…
Screening…See the label findings - Bizengri zenocutuzumab
Bispecific HER2-and HER3-directed antibodyAdults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with…
Screening…See the label findings - Imfinzi durvalumab
Programmed death-ligand 1 blocking antibodyAdults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy…
Screening…See the label findings - Ziihera zanidatamab-hrii
Bispecific HER2-directed antibodyThe first-line treatment of adult patients with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric…
3/6Special-handling language in the labelSee the label findings - Revuforj revumenib
Menin inhibitorRelapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized…
Screening…See the label findings - Scemblix asciminib
Kinase inhibitorAdult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP)
Screening…See the label findings - Vyloy zolbetuximab
Claudin 18.2-directed cytolytic antibodyThe first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)‑negative…
Screening…See the label findings - Itovebi inavolisib
Kinase inhibitorAdults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative…
Screening…See the label findings - Opdivo nivolumab
Programmed death receptor-1 blocking antibodyAdults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor…
Screening…See the label findings - Retevmo selpercatinib
Kinase inhibitorAdult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as…
Screening…See the label findings - Tagrisso osimertinib
Kinase inhibitorAdult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or…
Screening…See the label findings - Sarclisa isatuximab-irfc
CD38-directed cytolytic antibodyAdults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT)
Screening…See the label findings - Rybrevant amivantamab-vmjw
Bispecific EGF receptor-directed and MET receptor-directed antibodyAdult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19…
Screening…See the label findings - Keytruda pembrolizumab
Programmed death receptor-1-blocking antibodyUnresectable advanced or metastatic malignant pleural mesothelioma
Screening…See the label findings - Kisqali ribociclib
Kinase inhibitorThe adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and…
Screening…See the label findings - Tecentriq Hybreza atezolizumab and hyaluronidase-tqjs
Programmed cell death ligand 1 blocking antibodySubcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq, Genentech, Inc
Screening…See the label findings - Lazcluze lazertinib
Kinase inhibitorThe first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth…
Screening…See the label findings - Imfinzi durvalumab
Programmed death-ligand 1 blocking antibodyAdults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor…
Screening…See the label findings - Lymphir denileukin diftitox-cxdl
IL2-receptor-directed cytotoxinAdult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy
Screening…See the label findings - Voranigo vorasidenib
Isocitrate dehydrogenase-1 and isocitrate dehydrogenase-2 inhibitorAdult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1…
Screening…See the label findings - Jemperli dostarlimab-gxly
Programmed death receptor-1–blocking antibodyAdult patients with primary advanced or recurrent endometrial cancer (EC)
Screening…See the label findings - Darzalex Faspro daratumumab and hyaluronidase-fihj
Immunoglobulin G1 kappa human monoclonal antibodyInduction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT)
Screening…See the label findings - Epkinly epcoritamab-bysp
Bispecific CD20-directed CD3 T-cell engagerAdult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
Screening…See the label findings - Krazati adagrasib
Inhibitor of the RAS GTPase familyAdults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have…
Screening…See the label findings - Keytruda pembrolizumab
Programmed death receptor-1-blocking antibodyAdult patients with primary advanced or recurrent endometrial carcinoma
Screening…See the label findings - Blincyto blinatumomab
Bispecific CD19-directed CD3 T-cell engagerAdult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic…
Screening…See the label findings - Imfinzi durvalumab
Programmed death-ligand 1 blocking antibodyAdult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR)
Screening…See the label findings - Augtyro repotrectinib
Kinase inhibitorAdult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion…
Screening…See the label findings - Retevmo selpercatinib
Kinase inhibitorAdult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic…
Screening…See the label findings - Retevmo selpercatinib
Kinase inhibitorPediatric patients two years of age and older
Screening…See the label findings - Imdelltra tarlatamab-dlle
Bispecific delta-like ligand 3-directed CD3 T-cell engagerAdult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy
Screening…See the label findings - Tivdak tisotumab vedotin-tftv
Tissue factor-directed antibody and microtubule inhibitor conjugateRecurrent or metastatic cervical cancer with disease progression on or after chemotherapy
Screening…See the label findings - Ojemda tovorafenib
Kinase inhibitorPatients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or…
Screening…See the label findings - Lutathera lutetium Lu 177 dotatate
Radiolabeled somatostatin analogPediatric patients 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs)…
Screening…See the label findings - Anktiva nogapendekin alfa inbakicept-pmln
Interleukin-15 receptor agonistAdult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors
Screening…See the label findings - Alecensa alectinib
Kinase inhibitorAdjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC)…
Screening…See the label findings - Enhertu fam-trastuzumab deruxtecan-nxki
HER2-directed antibody and topoisomerase inhibitor conjugateAdult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no…
Screening…See the label findings - Elahere mirvetuximab soravtansine-gynx
Folate receptor alpha-directed antibody and microtubule inhibitor conjugateAdult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one…
Screening…See the label findings - Iclusig ponatinib
Kinase inhibitorAdult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)
Screening…See the label findings - Tevimbra tislelizumab-jsgr
Programmed death receptor-1-blocking antibodyThe first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1)
Screening…See the label findings - Brukinsa zanubrutinib
Kinase inhibitorRelapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
Screening…See the label findings - Opdivo nivolumab
Programmed death receptor-1 blocking antibodyFirst-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC)
Screening…See the label findings - Besponsa inotuzumab ozogamicin
CD22-directed antibody and cytotoxic drug conjugatePediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL)
Screening…See the label findings - Rybrevant amivantamab-vmjw
Bispecific EGF receptor-directed and MET receptor-directed antibodyThe first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)…
Screening…See the label findings - Tagrisso osimertinib
Kinase inhibitorPatients with locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) whose tumors have EGFR exon 19 deletions or exon 21…
Screening…See the label findings - Tepmetko tepotinib
Kinase inhibitorAdult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping…
Screening…See the label findings - Onivyde irinotecan liposome
Topoisomerase inhibitorThe first-line treatment of metastatic pancreatic adenocarcinoma
Screening…See the label findings - Balversa erdafitinib
Kinase inhibitorAdult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by…
Screening…See the label findings - Keytruda pembrolizumab
Programmed death receptor-1-blocking antibodyPatients with FIGO 2014 Stage III-IVA cervical cancer
Screening…See the label findings
2023 43 approvals
- Padcev enfortumab vedotin-ejfv
Nectin-4-directed antibody and microtubule inhibitor conjugatePatients with locally advanced or metastatic urothelial cancer (la/mUC)
Screening…See the label findings - Welireg belzutifan
Hypoxia-inducible factor inhibitorPatients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1)…
3/6Developmental / reproductive languageSee the label findings - Iwilfin eflornithine
Ornithine decarboxylase inhibitorAdult and pediatric patients with high-risk neuroblastoma
Screening…See the label findings - Jaypirca pirtobrutinib
Kinase inhibitorAdults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy…
4/6Carcinogenic / genotoxic findings in the labelSee the label findings - Ogsiveo nirogacestat
Gamma secretase inhibitorAdult patients with progressing desmoid tumors who require systemic treatment
Screening…See the label findings - Xtandi enzalutamide
Androgen receptor inhibitorNon-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR)
Screening…See the label findings - Truqap capivasertib
Kinase inhibitorAdult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic…
Screening…See the label findings - Keytruda pembrolizumab
Programmed death receptor-1-blocking antibodyThe first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ)…
Screening…See the label findings - Augtyro repotrectinib
Kinase inhibitorAdult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC)
Screening…See the label findings - Fruzaqla fruquintinib
Kinase inhibitorAdult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and…
Screening…See the label findings - Keytruda pembrolizumab
Programmed death receptor-1-blocking antibodyLocally advanced unresectable or metastatic biliary tract cancer (BTC)
Screening…See the label findings - Loqtorzi toripalimab-tpzi
Programmed death receptor-1-blocking antibodyCombination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or with recurrent, locally advanced…
Screening…See the label findings - Loqtorz toripalimab-tpzi
Programmed death receptor-1-blocking antibodyThe first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC)
Screening…See the label findings - Tibsovo ivosidenib
Isocitrate dehydrogenase-1 inhibitorAdult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as…
Screening…See the label findings - Rozlytrek entrectinib
Kinase inhibitorPediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known…
Screening…See the label findings - Keytruda pembrolizumab
Programmed death receptor-1-blocking antibodyResectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC)
Screening…See the label findings - Opdivo nivolumab
Programmed death receptor-1 blocking antibodyThe adjuvant treatment of completely resected Stage IIB/C melanoma in patients 12 years and older
Screening…See the label findings - Braftovi encorafenib
Kinase inhibitorAdult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test
Screening…See the label findings - Bosulif bosutinib
Kinase inhibitorPediatric patients 1 year of age and older with chronic phase (CP) Ph+ chronic myelogenous leukemia (CML) that is newly diagnosed (ND) or…
Screening…See the label findings - Elrexfio elranatamab-bcmm
Bispecific B-cell maturation antigen-directed CD3 T‑cell engagerAdult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome…
Screening…See the label findings - Hepzato Kit melphalan for injection/hepatic delivery system
Alkylating drugAdult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or…
Screening…See the label findings - Akeega niraparib and abiraterone acetate
Poly (ADP-ribose) polymerase inhibitorAdult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an…
Screening…See the label findings - Talvey talquetamab
Bispecific GPRC5D-directed CD3 T-cell engagerAdult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome…
Screening…See the label findings - Gavreto pralsetinib
Kinase inhibitorAdult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an…
Screening…See the label findings - Lonsurf trifluridine and tipiracil
Nucleoside analog antiviralMetastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF…
Screening…See the label findings - Jemperli dostarlimab-gxly
Programmed death receptor-1–blocking antibodyPrimary advanced or recurrent endometrial cancer (EC) that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or…
Screening…See the label findings - Vanflyta quizartinib
Kinase inhibitorCombination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following…
Screening…See the label findings - Talzenna talazoparib
Poly (ADP-ribose) polymerase inhibitorHomologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC)
Screening…See the label findings - Columvi glofitamab
Bispecific CD20-directed CD3 T-cell engagerAdult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma…
Screening…See the label findings - Lynparza olaparib
Poly (ADP-ribose) polymerase inhibitorAdult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as…
Screening…See the label findings - Epkinly epcoritamab-bysp
Bispecific CD20-directed CD3 T-cell engagerAdult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from…
Screening…See the label findings - Polivy polatuzumab vedotin-piiq
CD79b-directed antibody and microtubule inhibitor conjugateAdult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), or high-grade B-cell…
Screening…See the label findings - Padcev enfortumab vedotin-ejfv
Nectin-4-directed antibody and microtubule inhibitor conjugatePatients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy
Screening…See the label findings - Zynyz retifanlimab-dlwr
Programmed death receptor-1–blocking antibodyThe first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC)
Screening…See the label findings - Tafinlar dabrafenib
Kinase inhibitorPediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy
Screening…See the label findings - Verzenio abemaciclib
Kinase inhibitorThe adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative…
Screening…See the label findings - Jemperli dostarlimab-gxly
Programmed death receptor-1–blocking antibodyAdult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that…
Screening…See the label findings - Trodelvy sacituzumab govitecan-hziy
Trop-2-directed antibody and topoisomerase inhibitor conjugateUnresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0…
Screening…See the label findings - Orserdu elacestrant
Estrogen receptor antagonistPostmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)‑negative, ESR1…
Screening…See the label findings - Jaypirca pirtobrutinib
Kinase inhibitorAdult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK…
4/6Carcinogenic / genotoxic findings in the labelSee the label findings - Keytruda pembrolizumab
Programmed death receptor-1-blocking antibodyAdjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer…
Screening…See the label findings - Brukinsa zanubrutinib
Kinase inhibitorChronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Screening…See the label findings - Tukysa tucatinib
Kinase inhibitorRAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and…
3/6Developmental / reproductive languageSee the label findings
2022 11 approvals
- Lunsumio mosunetuzumab
Bispecific CD20-directed CD3 T-cell engagerAdult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
Screening…See the label findings - Krazati adagrasib
Inhibitor of the RAS GTPase familyAdult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved…
Screening…See the label findings - Rezlidhia olutasidenib
Isocitrate dehydrogenase-1 inhibitorAdult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as…
Screening…See the label findings - Elahere mirvetuximab soravtansine
Folate receptor alpha-directed antibody and microtubule inhibitor conjugateAdult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal…
Screening…See the label findings - Tecvayli teclistamab-cqyv
Bispecific B-cell maturation antigen-directed CD3 T-cell engagerAdult patients with relapsed or refractory multiple myeloma in combination with daratumumab and hyaluronidase-fihj in patients who have…
Screening…See the label findings - Imjudo tremelimumab
Cytotoxic T-lymphocyte-associated antigen 4 blocking antibodyAdult patients with unresectable hepatocellular carcinoma (uHCC)
Screening…See the label findings - Lytgobi futibatinib
Kinase inhibitorAdult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast…
Screening…See the label findings - Pluvicto lutetium lu 177 vipivotide tetraxetan
Radioligand therapeutic agentCombination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane…
5/6Carcinogenic / genotoxic findings in the labelSee the label findings - Opdualag nivolumab and relatlimab-rmbw
Fixed-dose combination of two IgG4 kappa monoclonal antibodies (mAbs)Adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma
Screening…See the label findings - Vonjo pacritinib
Kinase inhibitorAdults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF)…
Screening…See the label findings - Kimmtrak tebentafusp
Bispecific gp100 peptide-HLA-directed CD3 T cell engagerHLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma
Screening…See the label findings
2021 13 approvals
- Scemblix asciminib hydrochloride
Kinase inhibitorAdult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP)
Screening…See the label findings - Tivdak tisotumab vedotin
Tissue factor-directed antibody and microtubule inhibitor conjugateAdult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
Screening…See the label findings - Exkivity mobocertinib succinate
Kinase inhibitorAdult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20…
Screening…See the label findings - Welireg belzutifan
Hypoxia-inducible factor inhibitorAdult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system…
3/6Developmental / reproductive languageSee the label findings - Rylaze asparaginase erwinia chrysanthemi (recombinant)-rywn
Asparagine specific enzymeA component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma…
Screening…See the label findings - Truseltiq infigratinib phosphate
Kinase inhibitorAdults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2…
Screening…See the label findings - Lumakras sotorasib
Inhibitor of the RAS GTPase familyAdult patients with KRAS G12C -mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved…
Screening…See the label findings - Rybrevant amivantamab-vmjw
Bispecific EGF receptor-directed and MET receptor-directed antibodyThe first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth…
Screening…See the label findings - Zynlonta loncastuximab tesirine
CD19-directed antibody and alkylating agent conjugateAdult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell…
Screening…See the label findings - Jemperli dostarlimab
Programmed death receptor-1–blocking antibodyAdult patients with primary advanced or recurrent endometrial cancer (EC)
Screening…See the label findings - Fotivda tivozanib hydrochloride
Kinase inhibitorAdult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies
Screening…See the label findings - Ukoniq umbralisib tosylate
Kinase inhibitorAdult patients with: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen ( 1
Screening…See the label findings - Tepmetko tepotinib hydrochloride
Kinase inhibitorAdult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping…
Screening…See the label findings
Each month’s new cancer drugs, screened, in your inbox.
Source: Drugs@FDA original NDA/BLA approvals, FDA's oncology approval notices and the FDA package insert of record, refreshed weekly (last 2026-10-13). New drugs are new molecules only, no biosimilars, generics or new forms; new uses are FDA's own notices, cell and gene therapies aside.