Bristol Myers: Abecma approved by the European Union
Abecma demonstrated superiority over standard treatment regimens in the phase 3 KarMMa-3 trial, with a 51% reduction in the risk of disease progression or death, and a well-established safety profile, with mainly transient and low-grade occurrences of cytokine release syndrome and neurotoxicity.
' 'Today's approval in the European Union marks an important milestone in our efforts to bring the transformative potential of cell-based therapies to the front lines of treatment,' said Monica Shaw, M.D., senior vice president and head of European markets at Bristol Myers Squibb.
' Abecma is an important treatment option for patients with relapsed and refractory triple class multiple myeloma who have received at least two prior therapies, and paves the way for a promising shift in the treatment paradigm. '
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