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

SPS commentary:

Melflufen is a first in class peptide-drug conjugate that targets aminopeptidases and rapidly releases alkylating agent into tumour cells.


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