Following an earlier snub, the US Food and Drug Administration has now approved Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG).
Developed by California, USA-based ImmunityBio (Nasdaq: IBRX), the drug is authorized for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
Anktiva is expected to be available in the USA, by mid-May 2024, said ImmunityBio, whose shares edged up 1.8% to $5.04 on the news.
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