FDA grants Priority Review of New Drug Application for melflufen (melphalan flufenamide) as treatment of patients with triple-class refractory multiple myeloma
Application is seeking approval, in combination with dexamethasone for the treatment of adult patients with multiple myeloma whose disease is refractory to ≥1 proteasome inhibitor, 1 immunomodulatory agent and 1 anti-CD-38 monoclonal antibody and is based on phase 2 HORIZON study
Source:
Biospace Inc.
SPS commentary:
Melflufen is a first in class peptide-drug conjugate that targets aminopeptidases and rapidly releases alkylating agent into tumour cells.