Bristol Myers Squibb’s Abecma: First CAR T Cell Therapy Approved in EU for Multiple Myeloma

Bristol Myers Squibb (NYSE: BMY) has announced that the European Commission (EC) has granted approval to Abecma® (idecabtagene vicleucel; ide-cel) for treating adult patients with relapsed and refractory multiple myeloma who have undergone at least two prior therapies, including specific agents, and have shown disease progression on the last treatment. Abecma is the first chimeric antigen receptor (CAR) T cell immunotherapy approved in the European Union (EU) for use in earlier lines of therapy for this condition. This expanded approval covers all EU member states. In the EU, Abecma maintains its Orphan Designation for multiple myeloma treatment.

Today’s Approval of Abecma Represents a Milestone in Multiple Myeloma Treatment,” Says Bristol Myers Squibb

Monica Shaw, M.D., senior vice president and head of European Markets at Bristol Myers Squibb, expressed excitement about the approval of Abecma® (idecabtagene vicleucel; ide-cel) in the European Union. The approval marks a significant step in bringing innovative cell therapies to earlier lines of treatment for patients with triple-class exposed relapsed and refractory multiple myeloma.

The current treatment approach for multiple myeloma involves several classes of therapy, but many patients relapse or become refractory, highlighting the need for new options like Abecma. Dr. Paula Rodriguez-Otero from Clinica Universidad de Navarra in Spain emphasized the importance of innovative treatments that can offer long-term disease control for these patients.

Bristol Myers Squibb is ready to meet the increased demand for Abecma with its enhanced manufacturing capacity and high success rates globally. Abecma’s approval in Switzerland and Japan further underscores its efficacy in treating relapsed and refractory multiple myeloma.

Abecma is also approved in the U.S., Great Britain, and Israel for specific patient populations, with ongoing reviews and positive feedback from regulatory committees highlighting its promising benefit/risk profile. The company remains committed to advancing personalized therapies and improving outcomes for patients with this challenging condition.

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