Fda priority reviews applications for peptide-drug melflufen to treat refractic multiple myeloma.

The U.S. Food and Drug Administration (FDA) has given priority to Melflufen's new drug application, and Melflufen (INN melphalan flufenamide) is expected to treat multiple myeloma patients with protease inhibitors or immunomodulants or anti-CD-38 monoclonal antibodies in association with dexamisund, Oncopeptide announced today.
decision is based on the results of a key Phase II study, HORIZON, which evaluated the effectiveness and safety of intravenous Melflufen and dexamisong in the treatment of patients with recurring refractic multiple myeloma (RR MM).
, chief executive of Oncopeptides, said: "This is exciting news and an important step in Melflufen's treatment of patients with multiple myeloma."
Melflufen (INN melphalan flufenamide) is the first peptide-drug coupled (PDC) that targets amino peptide enzymes and rapidly releases alkanes into tumor cells.
Melflufen is quickly absorbed by myeloma cells due to its high pro-lipidity and is immediately hydrolyzed by peptide enzymes, releasing a packaged hydromassage agent load.
amino peptide enzymes are expressed in tumor cells and are more pronounced in advanced cancers and tumors with high mutation burden.
Melflufen is cytotoxic to myeloma cell strains, which are resistant to other treatments, including alkylation agents, and has been shown in preclinical studies to inhibit DNA repair and angiogenesis.
In the critical Phase 2 HORIZON study, the low rate of hematological AE and non-hematological AE in patients treating recurring refractic multiple myeloma showed encouraging efficacy and clinically controlled safety.
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