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BMS and bluebird bio gain FDA approval for multiple myeloma therapy

Abecma is a CAR T cell therapy approved for pre-treated myeloma patients

The US Food and Drug Administration (FDA) has approved Bristol Myers Squibb (BMS) and bluebird bio’s BCMA-targeting CAR T cell therapy Abecma – previously known as ide-cel – for the treatment of multiple myeloma.

The FDA has authorised Abecma 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, such as Janssen’s Darzalex (daratumumab).

In September, the FDA granted the CAR T cell therapy a priority review, after initially issuing a refuse-to-file letter in May 2020.

In its letter, the FDA asked BMS and bluebird for additional data before the agency processed and reviewed the submission.

Following this, BMS and bluebird re-filed the biologics licence application, saying that the new application provided further details about the chemistry, manufacturing and control (CMC) module of the submission to address the FDA’s initial concerns.

The eventual approval is based on results from the phase 2 KarMMa study of ide-cel, which evaluated the therapy of three doses in 128 patients who had received on average six previous therapies.

In this heavily pre-treated group, ide-cel induced an overall response rate of 81.5% and a complete response rate of 35.2%. Remissions in the study lasted an average of 10.6 months, and median progression-free survival reached 8.6 months.

Samit Hirawat, chief medical officer, BMS said: “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."

Nick Leschly, chief executive, bluebird bio said: “Our journey to today’s approval of Abecma started nearly a decade ago with pioneering research at bluebird bio and has been driven ever since by our mission to provide patients with multiple myeloma a new approach to fight this relentless disease.

“This achievement would not have been possible without all of the patients, caregivers, investigators and healthcare staff who participated in our clinical studies, as well as the tremendous collaboration with the FDA,” he added.

Abecma is manufactured using patients’ own T cells, which are collected and genetically modified to include a new gene that helps target and kill myeloma cells.

The CAR T cell therapy will be manufactured for each individual patient at BMS’ cellular immunotherapy manufacturing facility in Summit, New Jersey.

Article by
Lucy Parsons

29th March 2021

From: Regulatory



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