Abecma is the first treatment approved by EC for multiple myeloma
The European Commission (EC) has approved Abecma, the first anti-BCMA CAR T-cell therapy for patients with multiple myeloma.
Bristol Myers Squibb announced that the European Commission (EC) has granted conditional marketing authorisation (CMA) for Abecma (idecabtagene vicleucel), the first 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.
Abecma is the first and only approved CAR T cell therapy that is directed to recognise and bind to BCMA, leading to the death of BCMA-expressing cells. Abecma is delivered via a single infusion with a target dose of 420×106 CAR-positive viable T cells within a range of 260 to 500×106 CAR-positive viable T cells. It can be administered in patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
“The EC approval of Abecma is an important milestone for the treatment of multiple myeloma and moves us closer to offering a first-in-class, personalised therapy to patients in Europe battling this incurable disease after exhausting prior treatment options with the three standards of care,” commented Samit Hirawat, chief medical officer at Bristol Myers Squibb. “With this third regulatory approval for Abecma worldwide, we are proud to be advancing the science of cell therapy and continuing to bring this first anti-BCMA CAR T-cell therapy to patients in need.”
20 August 2021
https://www.europeanpharmaceuticalreview.com/
