FDA News

FDA fast tracks nanatinostat combination for Epstein-Barr virus-associated lymphoma

The FDA granted fast track designation to nanatinostat in combination with valganciclovir for the treatment of relapsed or refractory Epstein-Barr virus-positive lymphoid malignancies.

Nanatinostat (VRx-3996, Viracta Therapeutics) is an oral Class 1 histone deacetylase inhibitor. Valganciclovir is an antiviral medication used to treat cytomegalovirus infection among individuals with HIV/AIDS or those who underwent organ transplant.

The FDA based the fast track designation in part on interim data from the phase 1b portion of an ongoing phase 1b/phase 2a trial designed to assess nanatinostat in combination with valganciclovir for treatment of relapsed or refractory Epstein-Barr virus (EBV)-associated lymphomas.

Updated data from the trial will be presented at this year’s ASH Annual Meeting and Exposition, scheduled for Dec. 7-10 in Orlando, Fla.

“We are thrilled to receive fast track designation for our lead program and look forward to working closely with the FDA to bring this novel treatment option to patients,” Ivor Royston, MD, president and CEO of Viracta, said in a company-issued press release. “We believe our approach to EBV-associated lymphomas represents a novel treatment option for patients where the presence of EBV has not historically been actionable. We look forward to advancing our lead program toward registration studies in 2020 and expanding our clinical pipeline into additional EBV-positive malignancies.”

The FDA granted fast track designation to nanatinostat in combination with valganciclovir for the treatment of relapsed or refractory Epstein-Barr virus-positive lymphoid malignancies.

Nanatinostat (VRx-3996, Viracta Therapeutics) is an oral Class 1 histone deacetylase inhibitor. Valganciclovir is an antiviral medication used to treat cytomegalovirus infection among individuals with HIV/AIDS or those who underwent organ transplant.

The FDA based the fast track designation in part on interim data from the phase 1b portion of an ongoing phase 1b/phase 2a trial designed to assess nanatinostat in combination with valganciclovir for treatment of relapsed or refractory Epstein-Barr virus (EBV)-associated lymphomas.

Updated data from the trial will be presented at this year’s ASH Annual Meeting and Exposition, scheduled for Dec. 7-10 in Orlando, Fla.

“We are thrilled to receive fast track designation for our lead program and look forward to working closely with the FDA to bring this novel treatment option to patients,” Ivor Royston, MD, president and CEO of Viracta, said in a company-issued press release. “We believe our approach to EBV-associated lymphomas represents a novel treatment option for patients where the presence of EBV has not historically been actionable. We look forward to advancing our lead program toward registration studies in 2020 and expanding our clinical pipeline into additional EBV-positive malignancies.”