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

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.

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.