Bristol Myers Squibb (BMS) and 2seventy bio’s Abecma (idecabtagene vicleucel) has been approved by the US Food and Drug Administration (FDA) as an earlier-line treatment for patients with relapsed or refractory multiple myeloma.
The regulator has specifically authorised the CAR T-cell therapy for use in adults who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.
More than 35,700 new cases of multiple myeloma, a currently incurable blood cancer arising from plasma cells, are expected to be diagnosed in the US this year. While the course of the disease varies, many patients go on to relapse or become refractory to the three main classes of therapy.
The FDA’s decision comes less than a month after the European Commission approved Abecma for the same patient population and is supported by positive results from the late-stage KarMMa-3 study, which compared Abecma with standard combination regimens in adults with relapsed and refractory multiple myeloma after two to four prior lines of therapy.
Results showed that, at a median follow-up of 15.9 months, Abecma more than tripled the primary endpoint of progression-free survival (PFS) compared with standard regimens, with a median PFS of 13.3 months versus 4.4 months.
Results for the key secondary endpoint of overall response rate showed the majority of patients treated with Abecma achieved a response, with 39% achieving a complete response or stringent complete response. In comparison, less than half of patients who received standard regimens achieved a response, and 5% experienced a complete response or stringent complete response.
Bryan Campbell, senior vice president, head of commercial, cell therapy, BMS, said: “Abecma has demonstrated a PFS benefit three times that of standard regimens in relapsed or refractory multiple myeloma, and we are now bringing the promise of cell therapy to patients earlier in their treatment journey.”
Chip Baird, chief executive officer, 2seventy bio, said: “We are extremely pleased that Abecma will be available to many more patients in the US.
“This approval represents another important milestone for patients, for Abecma, and for 2seventy bio as we remain committed to increasing treatment options and working to improve outcomes for patients living with multiple myeloma.”
Abecma is being jointly developed and commercialised in the US by BMS and 2seventy bio, with BMS assuming sole responsibility for Abecma drug product manufacturing and commercialisation outside of the US.