NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday recommended that regulators approve Bristol Myers Squibb's autologous CAR T-cell therapy Abecma (idecabtagene vicleucel) as a third-line treatment for relapsed or refractory multiple myeloma patients.
The committee specifically recommended approval for the B-cell maturation antigen (BCMA)-directed cell therapy for patients who have received at least two prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. In the US, BMS jointly markets Abecma with 2seventy Bio, whereas BMS solely markets the drug in ex-US markets.
CHMP's recommendation is based on data from the Phase III KarMMa-3 clinical trial in which Abecma improved patient's progression-free survival versus standard-of-care treatments. The trial included patients who'd received between two and four prior therapies.
After a median follow-up of 30.9 months, patients treated with Abecma lived a median 13.8 months without their cancers progressing versus 4.4 months on standard regimens. This translates to a 51 percent reduction in disease progression or death with Abecma treatment.
In the US, Abecma is approved as a fifth-line treatment for relapsed or refractory multiple myeloma. Bristol Myers Squibb and 2seventy have sought approval for the cell therapy in an earlier-line indication, but the US Food and Drug Administration has delayed its decision because it is still reviewing the KarMMa-3 data. The FDA said in November that it will discuss the data with experts on its Oncologic Drugs Advisory Committee.
The cell therapy is also approved in the fourth- or fifth-line multiple myeloma setting in Europe and in the third-line setting in Japan.
The European Commission will now review CHMP's recommendation regarding Abecma's use in the earlier-line patient population and is expected to decide in approximately two months.