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October 25, 2021October 22, 2021 – Oncopeptides will withdraw Pepaxto® (melphalan flufenamide) from the United States market after a post-marketing clinical trial raised safety concerns. Pepaxto had received conditional FDA approval on February 26, 2021, to treat relapsed or refractory multiple myeloma in adults who met certain clinical criteria.
- In a clinical trial that compared Pepaxto to Pomalyst® (pomalidomide), a multiple myeloma drug from Bristol Myers Squibb, patients receiving Pepaxto had a higher risk of death and a shorter median overall survival time.
- The U.S. FDA issued a safety alert regarding Pepaxto in July 2021 and required suspension of enrollment in the post-marketing trial.
- In a press release, Oncopeptides stated the company "will work together with the FDA to continue to make the drug available for patients currently treated with Pepaxto."