Saturday, July 10, 2021

FDA green light for BMS, bluebird bio’s CAR-T therapy Abecma in multiple myeloma

Bristol Myers Squibb (BMS) and bluebird bio have received US Food and Drug Administration (FDA) approval for their CAR-T therapy Abecma in multiple myeloma.

Abecma (idecabtagene vicleucel; ide-cel) has been cleared for use in adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.

In the Phase II KarMMa trial, the overall response rate (ORR) for the efficacy evaluable population was 72% in multiple myeloma patients receiving the CAR-T therapy, with 28% of patients achieving a stringent complete response (sCR).

In addition, a median time to response of 30 days was observed, as well as a median duration of response of 11 months for all responders and 19 months for those who achieved sCR.

Of the patients who achieved sCR, an estimated 65% had remission lasting at least 12 months.

“CAR T cell therapies have shown transformational potential for the treatment of haematologic malignancies, and we, with our partners at bluebird bio, are proud to bring the first CAR T cell therapy to appropriate triple-class exposed patients with relapsed or refractory multiple myeloma, offering the chance for durable response,” said Samit Hirawat, chief medical officer of BMS.

Abecma is a personalised immune cell therapy which targets BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma cells.

The CAR-T therapy will be manufactured for each individual patient using their own T cells at BMS’ cellular immunotherapy manufacturing site in Summit, New Jersey in the US.

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