The company has contacted the US Food and Drug Administration and rescinded the October 22, 2021, letter requesting voluntary withdrawal of the NDA of Pepaxto (INN melphalan flufenamide, also called melflufen) in the US.
Further review and analyses of the heterogenous Overall Survival data from the phase 3 OCEAN study and other relevant trials have led the company to reconsider its previous voluntary withdrawal request, it states. Oncopeptides has discontinued the marketing of Pepaxto in the US and does not intend to market Pepaxto in the US at this time. The company has initiated a dialogue with the FDA to review the new data.
Photo of Jakob Lindberg, CEO, Oncopeptides