Screening report

TAIHO PHARMACEUTICAL CO., LTD. · Package insert of record

LYTGOBI (FUTIBATINIB)

Not on the NIOSH ListDailyMed (opens the full label on DailyMed in a new tab)
Carcinogenic / genotoxic findings in the label
The label reports carcinogenicity and/or genotoxicity findings — among the criteria NIOSH uses to identify hazardous drugs.
2 / 6NIOSH hazard criteria present in this label
Special handling: not found
Carcinogenicity: not found
Developmental: present in the label
Reproductive: not found
Genotoxicity: present in the label
Organ toxicity: not found
Genotoxicity / mutagenicity
2 passages in the label
Animal data

“…reverse mutation (Ames) assay. Futibatinib was clastogenic in an in vitro chromosomal aberration assay. Futibatinib was not clastogenic in a rat bone marrow micronucleus assay…”

1 more passage

“…Futibatinib was clastogenic in an in vitro chromosomal aberration assay. Futibatinib was not clastogenic in a rat bone marrow micronucleus assay or a rat DNA damaging (Comet) assay. Ded…”

Developmental / embryo-fetal toxicity
22 passages in the label

“…severity of hyperphosphatemia. ( 2.3 , 5.2 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential of the potential risk to the fetus and to use…”

2 more passages

“…[see Dosage and Administration (2.3) ] . 5.3 Embryo-Fetal Toxicity Based on findings in an animal study and its mechanism of action, LYTGOBI can cause fetal harm when administer…”

“…malformations, fetal growth retardation, and embryo-fetal death at maternal exposures lower than the human exposure at the clinical dose of 20 mg based on area under the curve (…”

Drug-class hint
Context only · not counted

“…lines of therapy. All patients received a prior platinum-based therapy including 91% with prior gemcitabine/cisplatin. Efficacy results are summarized in Table 5 . The median time to…”

Set aside: found but not counted (4)
NegatedCarcinogenicity: “OATP1B1, OATP1B3, MATE1, or MATE2K. 13 13.1 Carcinogenicity studies have not been conducted with futibatinib. Futibatinib was not mutagenic in an in vitro bacterial reverse m”
NegatedGenotoxicity / mutagenicity: “conducted with futibatinib. Futibatinib was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay. Futibatinib was clastogenic in an in vitro chromosomal aberra”
NegatedGenotoxicity / mutagenicity: “aberration assay. Futibatinib was not clastogenic in a rat bone marrow micronucleus assay or a rat DNA damaging (Comet) assay. Dedicated fertility studies with futibat”
NegatedGenotoxicity / mutagenicity: “was not clastogenic in a rat bone marrow micronucleus assay or a rat DNA damaging (Comet) assay. Dedicated fertility studies with futibatinib have not been conducted. 14 CLI”
These matched a hazard term but the text negates the finding, or names a test, a disease or a drug class rather than a finding about this drug. Shown so you can review them yourself.

For information only. This is a count of how many of the six NIOSH hazard-criteria appear in this label after negated and supporting-only statements are set aside. Findings from animal studies count, as NIOSH’s definition counts them, and are tagged “Animal data”. It is not a hazard determination, and the drug-class hint is not counted.