The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has endorsed Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T cell therapy, Abecma (idecabtagene vicleucel), for the treatment of relapsed and refractory multiple myeloma (r/r MM) in adults who have undergone at least two prior therapies. The European Commission (EC) will now evaluate this recommendation prior to making a regulatory approval decision.
The CHMP’s endorsement was informed by data from a Phase III study demonstrating a significant improvement in progression-free survival (PFS), which reached 13.8 months compared to just 4.4 months with standard combination regimens after a median follow-up of 30.9 months. This result reflects a 51% reduction in the risk of disease progression or death.
In addition to its current indication, Abecma is also being developed for use in earlier lines of treatment for multiple myeloma, according to the company’s press release.- Flcube.com
