A U.S. FDA advisory committee will meet to discuss Bristol Myers Squibb and 2seventy bio's supplemental BLA for blood cancer therapy Abecma, delaying the drug's PDUFA date.
The Oncologic Drugs Advisory Committee (ODAC) will review results from the pivotal phase 3 KarMa-3 study of Abecma in earlier lines of triple-class exposed relapsed or refractory multiple myeloma, the companies shared in a press release. While the date for the meeting has not been confirmed, it will mean that the agency will not meet the PDUFA target action date originally set for December 16, 2023.
While the KarMa-3 study of Abecma met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS), the partners anticipate that the committee will be looking at data related to the secondary endpoint of overall survival. Interim OS data, along with final PFS data, will be presented on December 11 at the 2023 American Society of Hematology Annual Meeting.
Abecma, jointly developed and commercialized by BMS and bluebird bio, which was spun out to create 2seventy bio, became the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma in March 2021. The drug was approved for use in adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy.
Multiple myeloma is an uncommon type of blood cancer in which abnormal plasma cells build up in the bone marrow and form tumors in many bones of the body. This disease keeps the bone marrow from making enough healthy blood cells, which can result in low blood counts. Each dose of Abecma is a customized treatment created by using a patient’s own T-cells to help fight the myeloma. The patient’s T-cells are collected and genetically modified to include a new gene that facilitates targeting and killing myeloma cells. Once the cells are modified, they are infused back into the patient.
