Nanatinostat and Valganciclovir Receive Orphan Drug Designation for Epstein Barr Virus–Positive DLBCL

By Sabrina Ahle - Last Updated: November 14, 2022

The U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) to nanatinostat and valganciclovir for the treatment of Epstein Barr virus–positive (EBV+) diffuse large B-cell lymphoma (DLBCL) not otherwise specified. Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor, selective for specific isoforms of class I HDACs that induce viral genes epigenetically silenced in EBV-associated malignancies. NAVAL-1, a phase II trial, will evaluate the anti-tumor activity of nanatinostat in combination with antiviral agent valganciclovir in 140 patients with various subtypes of relapsed/refractory EBV+ lymphoma.

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Previously, the FDA granted ODD to this combination for the treatment of T-cell lymphoma, post-transplant lymphoproliferative disorder, and plasmablastic lymphoma.

Source: Viracta Therapeutics news release, November 29, 2021.

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