BRIEF—Oncopeptides argues against Pepaxto withdrawal

Swedish biotech Oncopeptides has revealed details regarding the US Food and Drug Administration's  withdrawal of approval of Pepaxto (melphalan flufenamide).

A  public docket published by the regulator includes the company’s arguments on why it should remain available as “an important treatment option for multiple myeloma patients in later lines of treatment.”

Chief executive Sofia Heigis said: “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 USA.”

She added: “We value the opportunity to share our perspective and look forward to a continued dialogue with the FDA.”