The experts on Wednesday afternoon's panel will review clinical data on carfilzomib as a treatment for advanced multiple myeloma patients who are no longer responding to currently approved medicines. The FDA is asking the panel to vote on whether or not to recommend the approval of carfilzomib.
Carfilzomib, which will be sold under the brand name Kyprolis, shrank tumors in 22% of multiple myeloma patients but FDA, in its review, questioned whether cardiovascular and lung-related side effects undermine the drug's benefit."Since carfilzomib produced an ORR [overall response rate] of only 22% in the primary efficacy study, it may not provide an advantage over available therapy. FDA is very concerned with the severe toxicities, including deaths that are associated with the use of this agent," FDA stated in its review of the drug. If approved, carfilzomib will compete primarily against currently approved multiple myeloma drugs from Celgene (CELG) and Takeda. Onyx is technically seeking accelerated approval for carfilzomib based on results from a phase II study in which all patients were treated with the drug. If Wednesday's panel and later FDA decide these data are not sufficient to approve the drug, Onyx will fall back on an ongoing and larger phase III study with results expected next year. --Written by Adam Feuerstein in Boston.
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