After multiple regulatory setbacks on Bristol Myers Squibb’s lymphoma CAR-T drug Breyanzi caused investors headaches, the company on Friday scored its second cell therapy approval.
The FDA endorsed Abecma, formerly known as idecabtagene vicleucel, to treat adult multiple myeloma patients who have received four or more prior lines of therapy. With the approval, Abecma becomes the first CAR-T med licensed in multiple myeloma and the first B-cell maturation antigen-targeted (BCMA) CAR-T.
Friday’s approval was based on a phase 2 trial called KarMMa, which showed the drug triggered a response in nearly three-quarters of patients with heavily pre-treated and highly refractory multiple myeloma. The study tested the CAR-T drug in 128 patients.
While the drug has shown favorable efficacy, the FDA previously dealt BMS and its partner bluebird bio a rejection over manufacturing concerns. The partners made their way back to the FDA last year, and the agency granted a priority review.
CAR-T meds are created using a patient’s own T cells, which are extracted, genetically modified and then infused back into patients to help the body kill a disease.
RELATED: Bristol Myers Squibb in hot water after FDA rebuffs CAR-T therapy on manufacturing concerns
Abecma’s approval was one requirement for a multibillion-dollar contingent value right associated with BMS’ Celgene buyout, but setbacks on Breyanzi caused the payout to fall through.
The nod follows Breyanzi’s FDA approval last month to treat certain patients with large B-cell lymphoma who haven’t responded to two other systemic treatments or who have relapsed after receiving those treatments. But while there are now three licensed CAR-T lymphoma drugs, BMS’ Abecma is the only such drug in multiple myeloma.
RELATED: Bristol Myers, with Breyanzi nod in hand, eyes faster cell therapy production
On the heels of Breyanzi’s approval, BMS has been eying manufacturing improvements for the company’s cell therapy franchise. During a recent virtual manufacturing tour, BMS execs said the company is aiming to halve the time required to produce its CAR-T meds.
