The European Commission (EC) has approved Bristol Myers Squibb’s (BMS) cell therapy Abecma (idecabtagene vicleucel; ide-cel) to treat adults with relapsed and refractory multiple myeloma (r/r MM).
The approval specifies its use for patients who have received a minimum of two previous therapies and have shown disease progression since their last treatment.
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Abecma is a B-cell maturation antigen (BCMA)-directed genetically modified autologous therapy and the first chimeric antigen receptor (CAR) T cell immunotherapy to obtain approval in the European Union (EU) for earlier lines of therapy for r/r MM.
The approval is applicable in all EU member states.
The decision is based on the results from the KarMMa-3 study, a Phase III, open-label, global, randomised, controlled clinical trial.
Abecma was shown to improve progression-free survival, the trial’s primary endpoint, at pre-specified interim analysis with 18.6 months of median follow-up.
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By GlobalDataIt offered a 51% reduction in disease progression or mortality risk compared to standard regimens.
Abecma is currently approved in Switzerland for r/r MM patients who have received at least two prior lines of therapy and in Japan for patients with triple-class exposed r/r MM after two prior lines of therapy.
It is also approved for r/r MM indications in the US, Great Britain and Israel.
BMS senior vice-president and European Markets head Monica Shaw stated: “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.”
The latest development comes after the US Food and Drug Administration committee recently voted eight to three in favour of approving Abecma for r/r MM.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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