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Oncopeptides Weighing Pepaxto Withdrawal Request

 
• By Sue Sutter

Drama continues for the multiple myeloma treatment as US FDA formally moves to pull accelerated approval. Oncopeptides anticipates making a decision on the request in the first quarter of 2023.

Oncopeptides-FDA tug of war
The tug of war between FDA and Oncopeptides over withdrawal of Pepaxto continues. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock image

In a move that should come as no surprise to many, the US FDA has requested Oncopeptides AB withdraw the NDA for Pepaxto (melphalan flufenamide), but that development is not necessarily the end of the saga for the product.

The FDA request, announced by Oncopeptides on 7 December, comes more than two months after the Oncologic Drugs Advisory Committee...

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