The U.S. Food and Drug Administration (FDA) has granted priority review to Oncopeptide’s application seeking accelerated approval of melflufen (melphalan flufenamide) plus dexamethasone for people with relapsed or refractory multiple myeloma (RRMM). The new drug application was submitted in July and based on promising data from the HORIZON Phase 2 trial (NCT02963493). It 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. A decision is…
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