Oncopeptides rescinds voluntary withdrawal of Pepaxto in the US – no intent to market in the US at this time
STOCKHOLM — January 21, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the Company has contacted the US Food and Drug Administration and rescinded the October 22, 2021, letter requesting voluntary withdrawal of the NDA of Pepaxto[® ](INN melphalan flufenamide, also called melflufen) in the US.Further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