On April 16, 2021 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported that the Company has submitted an application to the European Medicines Agency, EMA, for conditional marketing authorization of melflufen (melphalan flufenamide) in the EU, based on the pivotal phase 2 HORIZON study in relapsed refractory multiple myeloma (Press release, Oncopeptides, APR 16, 2021, View Source [SID1234578134]). Pending a positive validation from the EMA, melflufen will be subject to a regulatory assessment according to the standard timelines.
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"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", says Marty J Duvall, Chief Executive Officer at Oncopeptides. "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", says Andrea Passalacqua, General Manager Europe, Oncopeptides. "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".
According to the European Medicines Agency, medicines are eligible for conditional approval if they are aimed at treating or preventing seriously debilitating or life-threatening diseases. Conditional marketing authorizations may be granted if the benefit-risk balance of the product is positive, comprehensive data can be provided, there is an unmet medical need, and the benefit to public health of making the product available outweighs the risks due to need for additional data.
On February 26th the U.S. Food and Drug Administration, FDA, approved PEPAXTO (melphalan flufenamide), in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.
The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person above, on April 16, 2021, at 08:00 (CET).