A New Drug Application has been submitted to the FDA seeking accelerated approval for melflufen, a new treatment for some patients with multiple myeloma.
If approved, the new drug would be for patients who have been refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD-38 monoclonal antibody, also known as triple-refractory, according to a release from the manufacturer.
The submission follows the completion of the phase 2 HORIZON trial, which studied the drug combined with dexamethasone.
The press release noted that the trial results were “durable and often deepened with prolonged treatment, suggesting that patients could benefit from staying on treatment for as long as possible.”
Jakob Lindberg, CEO of Oncopeptides, called the application a “major milestone” for the company, which now waits for the FDA to initiate an Expanded Access Program for melflufen.