EMA and FDA realize promise of CAR-T therapy in multiple myeloma

A CAR-T therapy targeting b-cell maturation antigen (BCMA) in previously treated patients with multiple myeloma, has been granted breakthrough therapy designation by the US Food and Drug Administration (FDA) and PRIME eligibility by the European Medicines Agency (EMA).

Preliminary early clinical date from an ongoing Phase I study has led the agencies to see the promise of bb2121, from US biotechs bluebird bio (Nasdaq: BLUE) and Celgene (Nasdaq: CELG).

The two companies are focusing on developing product candidates targeting BCMA and bb2121, their first program, delivered some of the most impressive Phase I data presented at this year’s ASCO event.