publication date: May. 24, 2019

Drugs & Targets

Oncopeptides to submit NDA for melflufen in multiple myeloma

After discussions with the FDA, Oncopeptides AB has initiated the preparation for submitting a New Drug Application for accelerated approval of melflufen for the treatment of patients with triple-class refractory multiple myeloma.

It plans to submit the application in the first quarter of 2020. This could then lead to the first melflufen market approval in the U.S. in 2020.

During the spring, Oncopeptides said it has been working with FDA to explore whether melflufen could be eligible for accelerated approval based on the promising data generated in the ongoing phase II HORIZON clinical trial.

The target indication would be for the treatment of patients with relapsed refractory multiple myeloma whose disease is triple-class refractory (refractory to at least one IMiD, one proteasome inhibitor and one anti-CD38 monoclonal antibody).

In the discussions, the FDA has requested and received all available clinical data at hand for melflufen.

Melflufen is a lipophilic peptide-conjugated alkylator that rapidly delivers a highly cytotoxic payload into myeloma cells through peptidase activity. It belongs to the novel class of Peptidase Enhanced Cytotoxics, which is a family of lipophilic peptides that exhibit increased activity via peptidase cleavage and have the potential to treat many cancers.

Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the peptidase cleavage, and induces irreversible DNA damage and apoptosis.

Melflufen displays cytotoxic activity against myeloma cell lines resistant … Continue reading Oncopeptides to submit NDA for melflufen in multiple myeloma

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