BMS & 2seventy Bio Announces the US FDA Review of sBLA for Abecma to treat Multiple Myeloma
Shots:
- The US FDA Oncologic Drugs Advisory Committee (ODAC) plans to review sBLA for Abecma (idecabtagene vicleucel) based on 2EP of OS in P-III study (KarMMa-3) for earlier lines of triple-class exposed r/r multiple myeloma
- The study (KarMMa-3) met its 1EP depicting statistically significant improvement in PFS & disease progression vs standard regime in patients. The safety results were consistent with previous data. The Final PFS & OS data will be presented at ASH
- The ODAC review & decisions will not be impacted by prior approvals or PDUFA target action date. Abecma is a CAR T cell treatment that binds to the BCMA surface of multiple myeloma cells, allowing CAR T cells to proliferate, secrete cytokines, & eventually destroy BCMA-expressing cells
Ref: BMS | Image: BMS
Related News:- BMS and 2seventy bio Report P-III Trial (KarMMa-3) Results of Abecma (idecabtagene vicleucel) for Multiple Myeloma
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
