Bristol Myers Squibb (BMS) has announced that Abecma (idecabtagene vicleucel) has been approved by the European Commission (EC) to treat patients with relapsed and refractory multiple myeloma.
The EU 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. Eligible patients will also have demonstrated disease progression on their last therapy.
Approximately 50,000 cases of multiple myeloma, a currently incurable blood cancer arising from plasma cells, are diagnosed each year in Europe. While the course of the disease varies, many patients go on to relapse or become refractory to the three main classes of therapy.
With the EC’s approval, Abecma is now the first CAR T-cell immunotherapy approved in the EU for use in earlier lines of therapy for relapsed and refractory multiple myeloma.
The decision follows a recent recommendation from the European Medicines Agency’s human medicines committee 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, with a median follow-up of 18.6 months, Abecma significantly improved progression-free survival (PFS) compared with standard regimens, with a median PFS of 13.8 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 43.7% 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.
Monica Shaw, senior vice president and head of European markets at BMS, said: “[The] approval in the EU marks an exciting milestone in our efforts to bring the transformative potential of cell therapies into earlier lines of treatment.
“Abecma is an important treatment option for patients with triple-class exposed relapsed and refractory multiple myeloma who have received at least two prior therapies and is leading the way toward a promising shift in the treatment paradigm.”
Abecma is being jointly developed and commercialised in the US by BMS and 2seventy bio, a spin-out of bluebird bio. BMS assumes sole responsibility for Abecma drug product manufacturing and commercialisation outside of the US.