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Carfilzomib Combo Approved for Relapsed Multiple Myeloma

Dr. Richard Pazdur

Sean E. Harper, MD

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.

This decision also converts carfilzomib’s single-agent accelerated approval in this setting to a full approval. In July 2012, the FDA granted an accelerated approval to carfilzomib monotherapy for the treatment of patients with multiple myeloma who have received at least 2 prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of the completion of the last therapy.

"Kyprolis is the only approved therapy for relapsed multiple myeloma with proven efficacy as a single agent, doublet and triplet combination that is offered in a variety of doses to meet individual patient needs," Sean E. Harper, MD, executive vice president of Research and Development at Amgen, said in a statement. "Importantly, this new approval supports the use of Kyprolis as a backbone therapy for the management of relapsed multiple myeloma, a difficult-to-treat blood cancer." Click here to read the full article at OncLive.com




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