BMS Reports the US FDA’s Acceptance of sBLA with Priority Review for Breyanzi (lisocabtagene maraleucel) to Treat Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Shots:
- The sBLA was accepted based on the results from the P-I/II (TRANSCEND CLL 004) trial evaluating the safety & efficacy of Breyanzi on r/r CLL or SLL patients (n=117). The application also received priority review with an expected PDUFA date of March 14, 2024
- The results from the cohort evaluated for the primary efficacy analysis set (PEAS, n=49) with Breyanzi at 100 x 106 CAR+ve viable T-cells, depicted an uMRD rate of 63.3% in the blood & 59.2% in bone marrow signifying an increase in PFS, ORR of 42.9%. & mDoR of 35.3mos. Moreover, the data from PEAS cohort were consistent with pretreated patients (with 5 prior LOT & high-risk disease) with a CR rate of 18.4%
- Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain responsible for enhancing the expansion & persistence of CAR T cells
Ref: BMS | Image: BMS
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
