Posted by Michael Wonder on 30 Aug 2020
FDA grants priority review of melflufen for patients with triple-class refractory multiple myeloma
29 August 2020 - Oncopeptides today announces that the US FDA has granted priority review for Oncopeptides' new drug application seeking approval of melphalan flufenamide, in combination with dexamethasone for the treatment of adult patients with multiple myeloma whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD-38 monoclonal antibody, (i.e., triple-class refractory multiple myeloma patients).
The FDA has set a PDUFA date of 28 February 2021.
