Bristol Myers’ Abecma approved in the EU for multiple myeloma

Bristol Myers announced that the European Commission has granted approval to Abecma for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Abecma is the first CAR T cell immunotherapy approved in the EU for use in earlier lines of therapy for relapsed and refractory multiple myeloma. This expanded approval of Abecma covers all EU member states. In the EU, Abecma has maintained its Orphan Designation for the treatment of multiple myeloma. There have historically been limited options for patients with triple-class exposed relapsed and/or refractory multiple myeloma, and patients tend to have poor outcomes with a median progression-free survival of three to five months. The company is focused on making Abecma available in the EU for this indication, including completion of reimbursement procedures. A supplemental BLA for Abecma for triple-class exposed relapsed and refractory multiple myeloma is currently under review with the FDA. The EC approval of Abecma is based on results from KarMMa-3, a Phase 3 study. At a pre-specified interim analysis with a median follow-up of 18.6 months, treatment with Abecma significantly improved progression-free survival, the study’s primary endpoint, vs. standard regimens, with a 51% reduction in the risk of disease progression or death. Treatment with Abecma also showed a significant improvement in overall response rate with 71.3% of patients treated with Abecma achieving a response, and 43.7% achieving a complete or stringent complete response vs. 42.4% who received standard regimens. Abecma has exhibited a consistent safety profile with mostly low-grade and transient occurrences of cytokine release syndrome and neurotoxicity. No cases of Parkinsonism were reported.