FDA grants orphan drug designation to nanatinostat and valganciclovir for lymphoma subset
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The FDA granted orphan drug designation to nanatinostat and valganciclovir for treatment of Epstein Barr virus-positive diffuse large B-cell lymphoma not otherwise specified.
Nanatinostat (VRx-3996, Viracta Therapeutics) is an orally available histone deacetylase (HDAC) inhibitor. The agent is selective for specific isoforms of class I HDACs, which helps induce viral genes that are epigenetically silenced in Epstein Barr virus-associated malignancies, according to a Viracta Therapeutics-issued press release.
Two phase 2 clinical trials are evaluating the agent in combination with the antiviral agent valganciclovir for Epstein Barr virus-positive lymphoma. A phase 1B/phase 2 trial is evaluating the combination for patients with Epstein Barr virus-positive nasopharyngeal carcinoma and other Epstein Barr virus-positive solid tumors.
The FDA previously granted orphan drug designation to nanatinostat and valganciclovir — often called Nana-val — for the treatment of T-cell lymphoma, plasmablastic lymphoma and post-transplant lymphoproliferative disorder.
“This latest orphan drug designation underscores the potential benefits of our all-oral kick-and-kill approach to targeting Epstein Barr virus-positive cancers," Ivor Royston, MD, president and CEO of Viracta Therapeutics, said in a company-issued press release. "Nana-val has shown promising preliminary efficacy across multiple subtypes of relapsed/refractory Epstein Barr virus-positive lymphoma, including DLBCL.”
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.
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