FDA withdraws accelerated approval of myeloma drug

The Food and Drug Administration Feb. 23 withdrew approval of Pepaxto (melphalan flufenamide), a drug once used with dexamethasone to treat certain U.S. patients with multiple myeloma, because a post-approval trial did not show it safe or effective. This is the first time the agency has used procedures amended under the Food and Drug Omnibus Report Act of 2022 to withdraw accelerated approval of a drug. The drug is not currently marketed in the U.S., FDA said.