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FDA Withdraws MM Treatment from Market

May 9, 2024

June 2024

The U.S. Food and Drug Administration (FDA) announced its decision to withdraw Oncopeptides’ melphalan flufenamide from the market as a treatment for multiple myeloma (MM).

The treatment received accelerated approval in February 2021 to treat patients with MM who had received four or more prior lines of therapy and were refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed antibody. Accelerated approval was granted based on the results of a single-arm phase II study.

Following accelerated approval, Oncopeptides conducted a controlled, randomized phase III trial comparing melphalan flufenamide and dexamethasone to pomalidomide and dexamethasone. Results did not demonstrate clinical benefit in progression-free survival but did demonstrate decrease in overall survival.

Data from the phase III trial prompted the FDA’s Oncologic Drugs Advisory Committee to meet on September 22, 2022, where they voted that the benefit-risk profile of melphalan flufenamide was not favorable for the indicated patient population. This compelled the Center for Drug Evaluation and Research to initiate the withdrawal process on July 7, 2023. Oncopepetides appealed the withdrawal, and the FDA came to a final decision in late February.

“I recognize that the decision to withdraw [melphalan flufenamide] might be upsetting for patients who have exhausted all their options among drugs approved for their condition, and for their loved ones and providers,” Peter W. Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, wrote in the final decision letter. “However, I believe that patients deserve FDA-approved treatments that are safe and effective.”

The treatment has full marketing authorization in Europe, where Oncopeptides will continue to focus its work, the company said in a press release.

Source: Oncopeptides, February 23, 2024. FDA, February 23, 2024.

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