Oncopeptides Withdraws Pepaxto After Phase 3 Trial

The company’s decision to take melphalan flufenamide off the market was made after dialogue and interactions with the FDA.

Oncopeptides said it will withdraw melphalan flufenamide (Pepaxto) from the United States market, following the phase 3 OCEAN study, the company said in a statement.

“Oncopeptides is committed to work closely with the regulatory authorities to evaluate the most appropriate possibilities for our pipeline products,” Jakob Lindberg, chief scientific officer at the company, said in the statement.

The decision was made after interactions and dialogue with the FDA, which granted melphalan flufenamide accelerated approval in early 2021.

Oncopeptides will refocus and return to being a research and development (R&D) company to further develop a proprietary peptide drug conjugated platform for next-generation drug candidates, including OPD5 and OPDC3.

“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,” Marty Duvall, chief executive officer at Oncopeptides, said in the statement.

The commercial business units in Europe and the United States will close, and the Stockholm, Sweden-based organization will be significantly reduced.

The company will work with the FDA to continue to make the drug available for individuals who use it.

Reference

Oncopeptides withdraws Pepaxto in US, scale down organization and focus on R&D. Oncopeptides. News release. October 22, 2021. Accessed November 5, 2021. https://www.oncopeptides.com/en/media/press-releases/oncopeptides-withdraws-pepaxto-in-us-scale-down-organization-and-focus-on-rd