Screening report

Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc. · Package insert of record

ANKTIVA (NOGAPENDEKIN ALFA INBAKICEPT-PMLN)

Not on the NIOSH ListDailyMed (opens the full label on DailyMed in a new tab)
Carcinogenicity in animal studies
The label reports carcinogenicity findings from animal studies only. NIOSH counts animal evidence; review the dose and species context.
2 / 6NIOSH hazard criteria present in this label
Special handling: not found
Carcinogenicity: present in the label
Developmental: present in the label
Reproductive: not found
Genotoxicity: not found
Organ toxicity: not found
Carcinogenicity
1 passage in the label
Animal data

“…activity when compared to BCG alone, in a carcinogen-induced model of bladder cancer in immunocompetent rats. 12.2 Pharmacodynamics The exposure-response relationship and t…”

Developmental / embryo-fetal toxicity
8 passages in the label

“…void while seated to avoid splashing of urine. Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females t…”

2 more passages

“…cystectomy. 8 Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 8.1 ,…”

“…on its mechanism of action, ANKTIVA may cause fetal harm when administered to a pregnant woman if systemic exposure occurs [see Clinical Pharmacology ( 12.1 )] . There are no a…”

Set aside: found but not counted (3)
NegatedCarcinogenicity: “alfa inbakicept-pmln products. 13 13.1 Carcinogenicity and genotoxicity studies have not been conducted with nogapendekin alfa inbakicept-pmln. Fertility studies with no”
NegatedGenotoxicity / mutagenicity: “products. 13 13.1 Carcinogenicity and genotoxicity studies have not been conducted with nogapendekin alfa inbakicept-pmln. Fertility studies with nogapendekin alfa i”
NegatedDevelopmental / embryo-fetal toxicity: “a drug-associated risk. Animal reproductive and developmental toxicity studies have not been conducted with nogapendekin alfa inbakicept-pmln. Advise pregnant women and females of reproducti”
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.