The FDA announced its final decision to rescind approval of melphalan flufenamide, citing safety concerns.
The agency approved melphalan flufenamide (Pepaxto, Oncopeptides) for use in combination with dexamethasone to treat certain patients with multiple myeloma in February 2021 under the Accelerated Approval Program.
A few months later, in July, the FDA alerted patients and health care providers about clinical trial results that showed an increased mortality risk among patients treated with the drug. In October, the manufacturer pulled the therapy from the market.
The decision, which is
