Viracta Therapeutics Inc. (NASDAQ: VIRX) has announced that the FDA has awarded its all-oral combination drug candidate nanatinostta and valganciclovir orphan drug designation for Epstein Barr virus-positive diffuse large B-cell lymphoma (EBV DCBCL) treatment.
DLBCL accounts for around 25% Of new NHL cases
DLBCL is the most frequent subtype of non-Hodgkin lymphoma (NHL) in the United States and around the world. It accounts for about 25% of newly diagnosed NHL cases in the United States, with a subset of EBV+ patients. The FDA had previously given ODD for the use of the combination in plasmablastic lymphoma and T-cell lymphoma, post-transplant lymphoproliferative disease (PTLD) treatment.
CEO Ivor Royston said, “This latest orphan drug designation underscores the potential benefits of our all-oral kick and kill approach to targeting EBV-positive cancers. Nana-val has shown promising preliminary efficacy across multiple subtypes of relapsed/refractory EBV-positive lymphoma, including DLBCL. We are dosing patients in the pivotal NAVAL-1 trial, which includes patients with EBV-positive DLBCL, and look forward to its continued momentum with sites now open for enrollment in the U.S., Europe, and Asia. Through NAVAL-1’s progress, we aim to further develop Nana-val as a new and actionable therapy in indications where many patients recur from the standard of care and have particularly poor prognoses.”
Orphans drug designation offers the company many benefits
Investigational medicines and biologics designed to treat rare diseases that affect less than 200,000 persons in the United States are given orphan drug designations by the FDA. Orphan drug designation is anticipated to enable drug development for rare diseases, and it offers drug developers with several benefits, including tax incentives toward qualified clinical study costs, help with clinical trial design and drug development, certain FDA application fees exemption, and market exclusivity for up to seven years following regulatory approval for a condition or disease for which the drug has the orphan drug designation. Last year 31 of the 53 new drugs products that received FDA’s Centre for Drug Evaluation and research Approval were Orphan Designated products.
