FDA issues final decision to withdraw Pepaxto accelerated approval
On Friday, the US Food and Drug Administration (FDA) announced its final decision to withdraw the marketing authorization of Swedish biotech Oncopeptides’ (Nasdaq Stockholm: ONCO) Pepaxto (melphalan flufenamide), which was granted accelerated approved for use in combination with dexamethasone to treat certain patients with multiple myeloma in 2021.
Back in December 2022, the FDA called on Oncopeptides to withdraw Pepaxto, a decision that the company appealed but has now lost. The Swedish firm’s shares were down more than 20% at 6.00 by close of trading.
Oncopeptides said its focus now remains on commercialization in Europe where the company has a full marketing authorization.
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