FDA approves Kyprolis combination to treat multiple myeloma
The US Food and Drug Administration has approved Amgen’s (Nasdaq: AMGN) Kyprolis in combination with dexamethasone to treat patients with relapsed multiple myeloma, it has been announced.
The approval is based on the results of the Phase III ENDEAVOR study which showed patients with relapsed multiple myeloma treated with Kyprolis and dexamethasone achieved 50% greater progression-free survival (PFS) of 18.7 months compared to 9.4 months in those receiving the current standard treatment of Velcade (bortezomib) and dexamethasone.
The decision converts an initial accelerated approval of Kyprolis to full approval, said Amgen.
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