Oncopeptides AB, a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, announces that the company has decided to withdraw Pepaxto® (INN melphalan flufenamide) from the market in the US, following the phase 3 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 US Food and Drug Administration, FDA. Pepaxto was granted accelerated approval on February 26th 2021.
During our dialogue with FDA it has become evident that the FDA does not consider that the phase 3 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. The organization will be scaled down to increase our cash runway and focus on building a platform for longer term development and growth. The commercial business units in the US and Europe will be closed down and the Stockholm based organization will be significantly reduced.
The application to the European Medicines Agency, EMA, for a potential Conditional Marketing Authorization of melflufen (melphalan flufenamide) in the EU, based on the pivotal phase 2 HORIZON study in relapsed refractory multiple myeloma, remains pending. The company expects to receive a CHMP opinion in Q2, 2022.
"The decision to withdraw Pepaxto from the market has been a difficult decision, that has been made with great consideration and with the best intentions for patients and shareholders," says Marty J Duvall, Chief Executive Officer at Oncopeptides. "The Company now needs to refocus its resources and energy on R&D and remain true to its mission of bringing hope to patients through science. We believe that this is the only viable path forward to accomplish this goal."
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