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FDA clears ImmunityBio’s bladder cancer drug at 2nd attempt

April 23, 2024


Anktiva (nogapendekin alfa inbakicep, or N-803) can be used in combination with the BCG vaccine in non-muscle invasive bladder cancer (NMIBC) patients who had not responded to the BCG shot on its own, according to the FDA, which blocked the drug last year because of quality issues at a contract manufacturing plant used to make it.

The decision throws a lifeline to ImmunityBio, which refiled the drug last October and previously said it may struggle to remain in business if the FDA turned it down for a second time.

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