The Food and Drug Administration granted a priority review to the new drug application for melflufen in combination with dexamethasone for adults with relapsed and refractory multiple myeloma (RRMM) who had previously received multiple lines of therapy.
The Food and Drug Administration (FDA) granted a priority review designation to melflufen in combination with dexamethasone for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who had previously received multiple lines of therapy, according to the agent’s manufacturer, Oncopeptides.
The designation is based on data from the phase 2 HORIZON trial.
“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,” said Oncopeptides’ CEO Marty J. Duvall in a company-issued press release. “I am looking forward to a continuing dialogue with the FDA while we make the product available to RRMM patients in the U.S. through an expanded access program in an FDA-approved trial called sEAPort.”
The agency is set to make its decision on whether to approve the drug for this use by Feb. 28, 2021.