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Oncopeptides Rescinds Pepaxto Voluntary Withdrawal, Which Could Set Up Battle With US FDA

Executive Summary

After more review of clinical trial data, the myeloma drug’s sponsor wants to talk to the FDA again, but Oncopeptides execs said they cannot disclose the scientific details that led to the decision.

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EMA Gives Oncopeptides’ Multiple Myeloma Drug The Thumbs Up; Keeps US FDA In Loop

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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High-Stakes Meeting With EMA On The Cards For Oncopeptides’ Pepaxto

Oncopeptides is nearing the end of the regulatory review cycle in the EU for its multiple myeloma drug, melphalan flufenamide. The product has had an erratic journey in the US, where it was approved but then withdrawn, and the withdrawal was subsequently rescinded.

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