Policy & Regulation
Viracta receives FDA's FTD for nanatinostat -valganciclovir combination for treating EBV-associated lymphomas
13 November 2019 -

Oncology company Viracta Therapeutics Inc Tuesday announced the US Food and Drug Administration (FDA) Fast Track designation to facilitate and expedite development and review of nanatinostat in combination with valganciclovir for the treatment of relapsed/refractory Epstein-Barr virus (EBV)-positive lymphoid malignancies.

The Epstein-Barr virus (EBV) remains latent in a small subset of lymphatic cells for the duration of the patient's life. Under certain circumstances, such cells may undergo malignant transformation and become lymphoma.

Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class 1 HDACs which is key to inducing latent viral genes in EBV-associated malignancies.

In conjunction, the interim data from the company's Phase 1b portion of an ongoing Phase 1b/2a clinical trial of nanatinostat in combination with the antiviral valganciclovir in patients with relapsed/refractory EBV-associated lymphomas were provided to the US FDA in support of the Fast Track Designation request.

On 8 December 2019, the company's updated clinical data will be presented during an oral session at the American Society of Hematology (ASH) meeting in Orlando, Florida.



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