BMS Reports the US FDA’s Accelerated Approval of Breyanzi for Treating Follicular Lymphoma (FL)
Shots:
- The US FDA’s accelerated approval of Breyanzi for r/r FL adults treated with ≥2 previous lines of systemic therapy is based on the P-II (TRANSCEND FL) trial assessing its safety & efficacy to treat r/r indolent B-cell NHL incl. FL
- The study, in efficacy evaluable patients (n=94) treated with Breyanzi in the 3L + setting, showed a 95.7% ORR, 73.4% CR rate, mToR 1mos., with 80.9% of them maintaining a response at 12mos. while 77.1% of them maintaining at 18mos. & mDoR not attained. Furthermore, data highlighted at ICML'23 showed a 97% ORR in evaluable patients (n=101) with 94% attaining CR
- Furthermore, Breyanzi is recommended as a Category 2A therapy in NCCN guidelines for 3L & subsequent treatment for the same
Ref: BMS | Image: BMS
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
