IBRX - FDA Approves ImmunityBio's Bladder Cancer Drug Stock Rallies | Benzinga
Monday, the FDA approved ImmunityBio Inc’s (NASDAQ:IBRX) Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
The drug is combined with the BCG vaccine, mainly used against tuberculosis and as a common treatment for some forms of bladder cancer.
Last year in May, the FDA issued a complete response letter to Anktiva plus BCG treatment, citing deficiencies related to the FDA’s pre-license inspection of the company’s third-party contract manufacturing organizations.
“The FDA’s approval ...