The FDA has approved carfilzomib (Kyprolis) in combination with dexamethasone or with lenalidomide plus dexamethasone for patients with relapsed/refractory multiple myeloma following prior treatment with 1 to 3 lines of therapy, based on findings from the phase III ENDEAVOR trial.
In addition to the combination approvals, this decision also converts carfilzomib’s single-agent accelerated approval in this setting to a full approval. Carfilzomib is now approved as a monotherapy for the treatment of patients with relapsed or refractory multiple myeloma who have received 1 or more lines of therapy.
"Multiple myeloma remains an incurable disease where relapse inevitably occurs and over time patients become resistant to treatments," Ruben Niesvizky, MD, director of the Multiple Myeloma Center at Weill Cornell Medicine and New York-Presbyterian/Weill Cornell Medical Center, said in a statement. "As a clinician, I'm pleased with the tremendous progress that we have seen in the past 12 months in multiple myeloma treatment. This FDA approval is important because it provides physicians with flexible options for Kyprolis use in helping to manage this challenging disease."