ImmunityBio’s Anktiva Receives the US FDA’s Approval to Treat Non-Muscle Invasive Bladder Cancer (NMIBC)
Shots:
- ImmunityBio’s Anktiva + Bacillus Calmette-Guérin (BCG) has received the US FDA’s approval to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) and with/without papillary tumors. The US availability is anticipated by mid-May 2024
- The approval & BTD was based on the study of 77 evaluable patients depicting a CR rate 62% with the confidence interval of 73% and DoR >47mos, as of Nov 2023
- The DoR & subsequent mDoR evaluation is in progress. Among 58% CR patients, DoR is ≥12mos. & 40% had ≥24mos. DoR
Ref: ImmunityBio | Image: ImmunityBio
Relasted News:- ImmunityBio Reports P-II/III (QUILT 3.032) Trial Results of N-803 + BCG for the Treatment of Bladder Cancer
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