Oncopeptides announced today that it submitted an application for European marketing authorization of its melflufen therapeutic.
Conditional marketing authorization from the European Medicines Agency (EMA) is the aim for the company after its pivotal phase 2 Horizon study provided positive outcomes with melflufen (melphalan flufenamide) in treating relapsed refractory multiple myeloma, according to a news release.
Stockholm-based Oncopeptides touts the drug, marketed as Pepaxto in the U.S., as the first anticancer peptide-drug conjugate approved for multiple myeloma.
Pepaxto links a peptide carrier to a cytotoxic agent, resulting in a lipophilic compound that helps to deliver the therapeutic into cells to leverage aminopeptidases that are overexpressed in multiple myeloma cells and cause the release of the cytotoxic agents. It is administered once a month in a 30-minute infusion process.
The FDA awarded accelerated FDA approval to Pepaxto in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma on Feb. 26 and the company subsequently launched the drug and reported that it was used to treat patients last month.
“Following Oncopeptides´ launch in the US, we are broadening our geographical footprint and submitting an application for conditional marketing authorization of melflufen in Europe ahead of expectations,” Oncopeptides CEO Marty J. Duvall said in the release. “This major milestone marks the commitment of our organization to bring hope to multiple myeloma patients around the world, through innovative science.”
“This is vitally important and supports the development of a dedicated organization across Europe,” added Oncopeptides GM of Europe Andrea Passalacqua. “We believe that melflufen may address a growing medical need in patients with relapsed refractory multiple myeloma in Europe. In order to help accomplishing this, we have also introduced an Early Access Program that offers eligible patients access to melflufen ahead of a potential marketing authorization.”