The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for BMS’s Abecma (idecabtagene vicleucel; ide-cel) for adult multiple myeloma patients with relapsed and refractory multiple myeloma who have received at least two previous therapies.
The recommendation is a critical step towards making the chimeric antigen receptor (CAR) T cell therapy available in the European Union for these patients.
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The European Commission (EC) will now review CHMP’s recommendation.
Developed in partnership with 2seventy bio in the US, the therapy is solely commercialised by BMS outside the country.
The positive opinion from CHMP is based on data from the KarMMa-3 study, a Phase III trial that compared Abecma with standard combination therapies in adults who had previously undergone two to four lines of treatment and were refractory to their prior regimen.
Progression-free survival (PFS) was the trial’s primary endpoint, while key secondary endpoints included overall response rate and overall survival.
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By GlobalDataThe results demonstrated a median PFS of 13.8 months for patients treated with Abecma, a significant improvement compared to the 4.4 months observed with standard regimens.
Abecma was shown to have a well-established safety profile.
BMS haematology, oncology, cell therapy late clinical development senior vice-president and head Anne Kerber stated: “This positive CHMP opinion represents an important step toward bringing our potentially transformative first-in-class anti-BCMA CAR T cell therapy, Abecma, to more patients earlier in the multiple myeloma treatment paradigm to improve outcomes.
“We look forward to working with the European Commission with the shared goal of delivering innovative treatment options to more patients with continued unmet need.”
The latest development comes after BMS concluded the acquisition of Mirati Therapeutics for $5.8bn.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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