Abecma (idecabtagene vicleucel) becomes first CAR T Cell therapy approved in the European Union in earlier lines for triple-class exposed relapsed and refractory multiple myeloma.- BMS

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 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.

The current treatment paradigm for multiple myeloma includes IMiDs, PIs, and anti-CD38 monoclonal antibodies; however, many patients go on to relapse and/or become refractory to these classes of therapy. With increased use of the three main classes of therapy as combination regimens, more patients are becoming triple-class exposed earlier in their treatment journey. 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.

“As patients with multiple myeloma become exposed to the three main classes of therapy earlier in treatment and still experience relapsed and/or refractory disease, it is critical that we continue to add innovative treatment options to our arsenal that can potentially provide long-term disease control,” said Paula Rodriguez-Otero, M.D., Ph.D., Department of Hematology, Clinica Universidad de Navarra, Pamplona, Spain. “This expanded approval of ide-cel represents key progress in bringing a personalized therapy that delivers significantly improved, durable outcomes to patients with triple-class exposed relapsed and refractory multiple myeloma after two prior therapies.”

With a significant increase in manufacturing capacity and over 90% manufacturing success rate globally, Bristol Myers Squibb is prepared to meet increased demand for Abecma. The company is focused on making Abecma available in the EU for this indication, including completion of reimbursement procedures.

Based on the KarMMa-3 study, Abecma is also the first cell therapy approved in Switzerland for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapies and the first cell therapy approved in Japan for adult patients with triple-class exposed relapsed or refractory multiple myeloma after two prior lines of therapy.

Abecma is also approved in the U.S. for adult patients with triple-class exposed relapsed or refractory multiple myeloma after four or more prior lines of therapy and approved in Great Britain and Israel for adult patients with triple-class exposed relapsed and refractory multiple myeloma after three or more prior lines of therapy. A supplemental Biologics License Application for Abecma for triple-class exposed relapsed and refractory multiple myeloma is currently under review with the FDA. The FDA’s Oncologic Drugs Advisory Committee (ODAC) recently voted positively that Abecma demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma based on results from the pivotal Phase III KarMMa-3 study.