Bristol Myers Squibb and bluebird bio Announce European Commission Approval of Abecma (idecabtagene vicleucel), the World’s First Anti-BCMA CAR T Cell Therapy for Relapsed and Refractory Multiple Myeloma
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European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Bristol-Myers Squibb (BMS) and its partner bluebird bio recently jointly announced that the European Commission (EC) has granted conditional approvalAnti-B-cell maturation antigen (anti-BCMA)-directed chimeric antigen receptor (CAR) T-cell therapy Abecma (idecabtagene vicleucel, ide-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma (R/R MM), specifically: adult patients with relapsed or refractory multiple myeloma (R/R MM) who have previously received at least three prior therapies (including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody) and whose disease progressed during or after the last therapy. Previously, Abecma was granted Priority Medicines (PRIME) designation.
Abecma is a first-in-class, BCMA-directed, personalized immune cell therapy.BCMA is a protein that is almost universally expressed on multiple myeloma cancer cells.As an anti-BCMA CAR-T cell therapy, Abecma recognizes and binds to BCMA, leading to the death of BCMA-expressing cells.
Abecma is the world's first approved BCMA-directed CAR-T cell therapy.March 2021, United StatesFDAAbecma is approved for the treatment of adult patients with R/R MM. This drug is indicated for the treatment of adult patients with R/R MM who have received four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.
The market approval of Abecma will provide a new, effective, and personalized treatment option for these patients, enabling rapid, deep, and durable remission with a single infusion.In clinical studies, the safety of Abecma in treated patients has been well established. Cytokine release syndrome (CRS) and neurotoxicity (NT) were predominantly low-grade, with predictable early onset and rapid resolution.
Samit Hirawat, Chief Medical Officer of Bristol-Myers Squibb, said: “The European Commission’s approval of Abecma marks a significant milestone in the treatment of multiple myeloma, bringing us closer to providing European patients with a first-in-class, individualized therapy. With Abecma receiving its third regulatory approval globally, we are proud to advance the science of cell therapy and continue to deliver the first anti-BCMA CAR T-cell therapy to patients in need.”
Abecma is the world's first regulatory-approved BCMA CAR-T cell therapy. Its mechanism of action involves engineering a BCMA-targeting chimeric antigen receptor onto the patient's T cells. The manufacturing process is as follows: T cells are isolated from each patient's blood, and a lentivirus encoding the BCMA antigen receptor is used to...CarrierT cells are genetically engineered to express BCMA-targeting receptors on their surface. During treatment, multiple myeloma (MM) patients first receive preconditioning chemotherapy with two agents (cyclophosphamide and fludarabine) to deplete existing T cells, followed by an infusion of Abecma. Once administered, Abecma seeks out and destroys cells expressing BCMA.
Abecma is part of a co-development, co-promotion, and profit-sharing agreement between Bristol-Myers Squibb and bluebird bio, under which both parties will jointly develop and commercialize Abecma in the U.S. market. Bristol-Myers Squibb will be solely responsible for the manufacturing and commercialization of Abecma outside the United States.
This EU approval is based on data from the pivotal Phase 2 KarMMa study (NCT03361748). This pivotal, open-label, single-arm, multicenter, multinational Phase 2 study evaluated the efficacy and safety of Abecma in adult patients with relapsed and refractory multiple myeloma (R/R MM) in North America and Europe. The study enrolled a total of 140 patients, 128 of whom received Abecma at a target dose level of 150–450 × 10⁶ CAR-positive T cells following lymphodepleting chemotherapy. All enrolled patients had previously received at least three prior lines of therapy (including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody) and were refractory to their last regimen (defined as disease progression during or within 60 days of the final treatment). Among these 128 patients, the median number of prior lines of therapy was 6 (range: 3–16), and 84% (108/128) were triple-class refractory.
In May this year, Bristol-Myers Squibb and bluebird bio announced the latest analysis data from the KarMMa study (with over 2 years of follow-up). These data represent, to date, the globalClinical Trialthe longest follow-up.
Long-term data from the KarMMa trial continue to demonstrate that, with a median follow-up exceeding 2 years (24.8 months), Abecma exhibits durable efficacy and a predictable safety profile in patients with R/R MM. Among 128 patients,，median overall survival (OS) was 24.8 months, overall response rate (ORR) was 73%, with durable responses.The analysis of the neurotoxicity (NT) characteristics observed in this study reinforces the well-established safety profile of Abecma, with the majority of NT events being Grade 1/2, and characterized by early onset and rapid resolution.
These long-term data further demonstrate that Abecma provides clinically meaningful outcomes and a predictable safety profile for the R/R MM patient population, highlighting the advantages and transformative potential of this novel personalized therapy.