BMS Reports the US FDA’s Approval of Breyanzi for Treating Mantle Cell Lymphoma
Shots:
- The US FDA has approved Breyanzi for r/r MCL adults previously treated with at least 2L of systemic therapy (incl. BTK inhibitor), based on data from P-I (TRANSCEND NHL 001) trial’s MCL arm
- The P-I (TRANSCEND NHL 001) trial assesses Breyanzi's safety, PK & antitumor activity to treat r/r B-cell NHL (DLBCL, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, FL grade 3B & MCL)
- The results (n=68) showed, 85.3% treatment responders & 67.6% reached CR with median time to response of 1mos. & mDoR of 13.3mos. at 22.2mos. follow-up; 51.4% (12mos.) & 38.8% (18mos.) responders remaining in response. Primary analysis (n=83), published in JCO, depicted 83.1% ORR & 72.3% CR with mDoR of 15.7mos. & PFS of 15.3mos.
Ref: BMS | Image: BMS
Related News:- BMS Reports the US FDA’s Accelerated Approval of Breyanzi for Treating Follicular Lymphoma (FL)
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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.
