FDA grants priority review to melflufen for refractory multiple myeloma
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The FDA granted priority review to melflufen in combination with dexamethasone for the treatment of adults with triple-class refractory multiple myeloma, according to a manufacturer-issued press release.
This designation applies to patients whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD-38 monoclonal antibody.
Melflufen (INN melphalan flufenamide, Oncopeptides AB) is a first-in-class peptide-drug conjugate that targets aminopeptidases, which are overexpressed in tumor cells, especially those with high mutational burden. The agent works by rapidly releasing alkylating agents into tumor cells.
As Healio previously reported, melflufen plus dexamethasone showed encouraging efficacy and a manageable safety profile in the phase 2 HORIZON study.
“This is very exciting news. It is an important milestone for Oncopeptides, and a major step in making melflufen available for patients with multiple myeloma, who desperately need new treatment options,” Marty J. Duvall, CEO of Oncopeptides AB, said in the release. “I am looking forward to a continuing dialogue with the FDA while we make the product available to [patients with relapsed/refractory multiple myeloma] in the U.S. through an expanded access program, in an FDA-approved trial called sEAPort.”
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