Health Canada approves Abecma for multiple myeloma – BMS

Bristol Myers Squibb Canada announced Health Canada has granted conditional approval (NOC/c) for Abecma (idecabtagene vicleucel; ide-cel) as the first and only B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for adults with multiple myeloma (MM).

Abecma is indicated for MM patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and who are refractory to their last treatment. This conditional approval is based on the results of the pivotal Phase II KarMMa study which demonstrated Abecma’s ability to deliver rapid, deep and durable responses with a single infusion.

Comment: Abecma, a CAR T therapy, uses patients’ T cells to create a personalized version of their own immune system, potentially improving the chances of anti-tumour response long after treatment administration. As an anti-BCMA CAR T cell therapy, Abecma recognizes and binds to BCMA, a protein that is nearly universally expressed on cancer cells in MM, leading to the death of BCMA-expressing cells.