October 12, 2020 -- Oncopeptides plans to submit an application for a conditional marketing authorization of melflufen in the European Union (EU), based on the phase II Horizon study in relapsed refractory multiple myeloma.
Melflufen is a peptide-drug conjugate that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. The drug is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately hydrolyzed by peptidases to release its entrapped hydrophilic alkylator payload. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments and has been shown to inhibit DNA repair induction and angiogenesis in preclinical studies.
This decision is based on in-depth analysis of key opinion leaders in the EU, according to the firm. The Horizon study demonstrates that melflufen in combination with dexamethasone can be a successful treatment option. The European Medicines Agency may grant conditional marketing authorizations if there is unmet medical needs and the benefit-risk balance of the product is positive.
The company also noted that the U.S. Food and Drug Administration (FDA) has granted priority review to Oncopeptides' new drug application of melflufen in combination with dexamethasone for treatment of patients with multiple myeloma. The FDA plans to review the new drug application on February 28, 2021.