Nanatinostat plus valganciclovir granted Fast Track designation by the FDA for the treatment of patients with EBV-associated lymphomas

On the 12^th November 2019, the combination of nanatinostat with valganciclovir was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for use in patients with relapsed/refractory (R/R) Epstein-Barr virus (EBV)-positive lymphoma.¹

The Fast Track status was granted based on the positive interim data from the ongoing phase Ib/IIa clinical trial [NCT03397706], investigating the combination in patients with R/R EBV-positive lymphomas.² The combination was well tolerated and showed responses in B- and T-cell malignancies, with the overall response rate of 58%, complete response rate of 33%, and disease stabilization rate  of 75%. The updated clinical data are expected to be presented at the annual meeting of American Society of Hematology (ASH) in December 2019.

Nanatinostat (VRx-3996) is an orally available inhibitor of Class 1 histone deacetylase (HDAC), an enzyme important for epigenetic control of gene expression, including induction of genes responsible for EBV latency. The inhibition of HDAC reactivates the EBV lytic cycle in EBV-positive cells, sensitizing EBV-infected cells to antiviral therapy with valganciclovir and therefore enhancing the anti-tumour activity.