FDA Accelerated Approval of Melflufen Sought for Hard-to-treat Myeloma Patients

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FDA Accelerated Approval of Melflufen Sought for Hard-to-treat Myeloma Patients
August 05, 2020August 5, 2020
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Oncopeptides has submitted a new drug application to the U.S. Food and Drug Administration (FDA) requesting the accelerated approval of melflufen (melphalan flufenamide) plus dexamethasone for hard-to-treat patients with multiple myeloma. The application is specific for people with triple-refractory disease — those who failed to respond to at least one immunomodulatory agent (IMiD), one proteasome inhibitor, and one anti-CD38 monoclonal antibody. It is based on data from the HORIZON Phase 2 trial (NCT02963493), in which the combination therapy was found…

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