The European Medicines Agency has recommended EU-wide marketing approval for Pepaxti (melphalan flufenamide), Oncopeptides’ treatment for relapsed refractory multiple myeloma (RRMM).
EMA Gives Oncopeptides’ Multiple Myeloma Drug The Thumbs Up; Keeps US FDA In Loop
Company’s Request For EU Conditional Approval Flipped To Full Marketing Authorization
With Pepaxti now on track for pan-EU marketing approval to treat patients with triple class refractory multiple myeloma, Oncopeptides is in talks with the Food and Drug Administration to achieve a clear path forward for the drug in the US where it has experienced difficulties despite being granted an accelerated approval.
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