The European Commission expanded approval of Amgen's Kyprolis (carfilzomib) to include use in combination with dexamethasone alone for adults with multiple myeloma who have received at least one prior therapy, the company announced.
According to Amgen, approval was based on data from the ENDEAVOR trial, with results showing that patients with multiple myeloma treated with Kyprolis plus dexamethasone achieved progression-free survival of 18.7 months compared to 9.4 months for those given Johnson & Johnson and Takeda's Velcade (bortezomib) plus dexamethasone. In addition, Kyprolis plus dexamethasone demonstrated improvement over Velcade plus dexamethasone for secondary endpoints, including rates of complete response or better.
Kyprolis was first approved in Europe in November last year for use in combination with lenalidomide and dexamethasone for the treatment of adults with multiple myeloma who have received at least one prior therapy. Meanwhile, earlier this year, the FDA expanded clearance of the proteasome inhibitor based on the ENDEAVOR study results.
For related analysis, read KOL Views: New drugs are transforming how relapsed/refractory MM is treated, though more information and better access is needed, and for more information on the multiple myeloma treatment landscape, see Multiple Myeloma: KOL Insight.
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