On August 19, 2021, Abecma(Idecabtagene Vicleucel) Granted EMA Approval in the EU for the Treatment of Relapsed and Refractory Multiple Myeloma
On August 19, 2021, Abecma(Idecabtagene Vicleucel) Granted EMA Approval in the EU for the Treatment of Relapsed and Refractory Multiple Myeloma
Abecma Approved for Marketing in Europe
On August 19, 2021, Bristol Myers Squibb announced that the European Commission (EC) has granted conditional marketing authorization for Abecma (idecabtagene vicleucel; ide-cel), a first-in-class B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell immunotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (R/R MM) who have received at least four prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.
About Abecma
Abecma is a first-in-class, BCMA-directed, individualized immune cell therapy. BCMA is a protein that is widely expressed on multiple myeloma cancer cells. As an anti-BCMA CAR-T cell therapy, Abecma recognizes and binds to BCMA, leading to the destruction of BCMA-expressing cells.
Abecma is the first BCMA-directed CAR-T cell therapy to be approved globally. In March 2021, Abecma was approved by the U.S. FDA 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 therapy detects and attaches to BCMA, leading to CAR-T cell proliferation, cytokine secretion, and lysis of BCMA-expressing cells.
BMS noted that Abecma is the first-ever approved BCMA-targeted CAR-T cell therapy.
Samit Hirawat, Chief Medical Officer of BMS, stated, “The EC approval of Abecma is an important milestone in the treatment of multiple myeloma and brings us closer to providing a first-class, personalized therapy option for patients in Europe who have exhausted standard-of-care treatments.”
“With the third global regulatory approval for Abecma, we are proud to advance the science of cell therapy and continue to provide the first anti-BCMA CAR T-cell therapy to patients in need.”
Basis for Abecma’s Approval in Europe
Abecma’s conditional marketing authorization (CMA) was granted under the European Medicines Agency’s PRIME (Priority Medicines) program.
The approval was based on data from the pivotal KarMMa trial, which demonstrated the therapy’s favorable benefit-risk profile and predictable safety.
The trial enrolled 128 patients with relapsed and refractory multiple myeloma who had received at least three prior therapies.
The data showed an overall response rate (ORR) of 73% in patients treated with Abecma, with 33% of patients achieving a complete response (CR).
BMS added that responses were rapid, with a median time to response of 1 month, and durable, with a median duration of response (DOR) of 10.6 months.
For patients who achieved a CR, the median DOR was 23 months. The therapy was approved in the U.S. in March 2022 for the treatment of adult patients with R/R MM who have received four or more prior lines of therapy.
The approval of Abecma provides a new, effective, and personalized treatment option for these patients that can be administered in a single infusion, resulting in rapid, deep, and durable responses. In clinical studies, Abecma demonstrated a well-characterized safety profile, with cytokine release syndrome (CRS) and neurotoxicity (NT) mostly being low-grade, with predictable early onset and rapid resolution.