The submission was based on the P-II safety & efficacy evaluation of Breyanzi in (TRANSCEND FL) trial for r/r FL & in (TRANSCEND NHL 001) for r/rMC. ORR (Trial 1)/AEs, dose-limiting toxicities & ORR (Trial 2) were the 1EPs & CRR, DoR & PFS were the 2EPs in both trials
In (TRANSCEND FL), the results depicted an ORR of 97%, CR in 94% of patients, mDoR of 81.9% at 12mos. & not achieved at 16.6mos. & PFS in 80.7% of patients at 12mos. & not achieved at 17.5mos. In (TRANSCEND NHL 001) trial, at a median follow-up of 16.1mos., ORR was 86.5% & CR achieved in 74.3% of patients
The US FDA accepted the application for FL & MCL & granted Priority Review with a PDUFA date of May 23, 2024 & the Japan MHLW accepted the application for FL
Ref: BMS | Image: BMS
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