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Pepaxto withdrawn from market in US.- Oncopeptides

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Last updated:24th Oct 2021
Published:24th Oct 2021
Oncopeptides announced that the company has decided to withdraw Pepaxto (INN melphalan flufenamide) from the market in the US, following the phase III OCEAN study, which showed an overall survival in the ITT population with a HR of 1.104. The decision has been made after interactions and dialogue with the FDA. Pepaxto was granted accelerated approval on February 26th 2021.

During dialogue with FDA it has become evident that the FDA does not consider that the phase III OCEAN study meets the criteria of a confirmatory study. Oncopeptides believes that the OCEAN data are scientifically meaningful and that the findings warrant further evaluation. As a consequence Oncopeptides will immediately refocus the company and return to being a Sweden based R&D company, dedicated to further develop our proprietary Peptide Drug Conjugate (PDC) platform including the next generation of drug candidates including OPD5 and OPDC3.

Condition: Multiple Myeloma
Type: drug

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