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Oncopeptides’ Melflufen: Same Data, Different Conclusions From EMA, US FDA

 
• By Francesca Bruce

The two regulators were an OCEAN apart on their interpretation of the overall survival and progression-fee survival data from the Phase III confirmatory trial. European regulators saw fit to recommend Pepaxti’s approval, even after the drug was voluntarily discontinued in the US market due to FDA concerns.

Atlantic Ocean
EU and US regulators were an OCEAN apart in their conclusions on melflufen's efficacy. • Source: Shutterstock

The future of Oncopeptides AB’s multiple myeloma treatment Pepaxto (melphalan flufenamide) in the US remains hazy given the company’s decision in 2021 to discontinue marketing the drug, although it has not yet formally agreed to the Food and Drug Administration’s request to withdraw the new drug application.

However, the same drug, branded as Pepaxti, lives on in the EU, where regulators overcame several concerns that the FDA cited as reasons why the drug should come off the US market

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