Information regarding Oncopeptides’ appeal of U.S. withdrawal published
Stockholm – August 25, 2023 – Oncopeptides AB (publ), a biotech company focused on difficult-to-treat cancers, today announces that more information regarding the formal request from the U.S. Food and Drug Administration (FDA) to voluntarily withdraw Pepaxto´s approval in the U.S has been made available by the FDA.
The public docket contains, among other documents, a detailed appeal document outlining Oncopeptides´ arguments for why Pepaxto should remain on the U.S. market as an important treatment option for multiple myeloma patients in later lines of treatment.
“Our OCEAN study demonstrated clinical benefit for multiple myeloma patients, in particular for non-transplanted elderly patients where the unmet medical need remains very high, and we remain confident that it would provide value for patients all over the world, including the U.S.,” says Sofia Heigis, CEO of Oncopeptides. “We value the opportunity to share our perspective and look forward to a continued dialogue with the FDA.”
Please visit Oncopeptides' website for additional information, including a Q&A for investors.