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FDA Medication Tracker

← All approvals · Cancer · 2024

Anktiva (nogapendekin alfa inbakicept-pmln)

The FDA approved Anktiva (nogapendekin alfa inbakicept-pmln) on April 22, 2024 to treat bladder cancer.
Brand name
Anktiva
Generic name
nogapendekin alfa inbakicept-pmln
FDA approval date
April 22, 2024
Approved use (FDA wording)
To treat bladder cancer
Company
Altor Bioscience, LLC, An Indirect Wholly-Owned Su
Application
BLA761336
Dosage form / route
SOLUTION · INTRAVESICAL
Boxed warning on label
Not listed
Category on this site
Cancer

Indications and usage, from the FDA label

ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.