General MM

BCMA CAR T-cell (bb2121) granted both breakthrough therapy designation and PRIME status

The anti–B-cell maturation antigen (BCMA) CAR T-cell bb2121 has been granted both breakthrough therapy designation by the US Food and Drug Administration (FDA) and PRIority MEdicines (PRIME) eligibility by the European Medicines Agency (EMA). Achieving this EMA and FDA status will help to speed up the development process, and is granted to drugs that are highly promising and could change the course of current treatment.

No new data was released with this application, but the latest clinical trial data (phase I CRB-401) treating patients with Relapsed and Refractory Multiple Myeloma (RRMM), is due to be presented at the 59th American Society of Hematology (ASH) 2017 Annual Meeting and Exposition on Monday 11th December at 20:00 GMT – look out for MM Hub coverage next week. Data from the first analysis of the study with 21 patients was revealed in June this year at both the European Hematology Association (EHA) 22nd Annual Congress and also at the American Society of Clinical Oncology (ASCO) Annual Meeting – see MM Hub article.

This will be welcome news for Celgene and Bluebird Bio who are developing bb2121 and plan to extend the clinical trial with the recruitment of 50 new participants. Eligible patients must have undergone 3 prior treatments, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or must be double-refractory, and have ≥50% BCMA expression on the relevant cells. 

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