|Indication||Preclinical||Early-Stage Clinical||Late-Stage Clinical||Regulatory Submission|
|Relapsed/Refractory EBV+ Lymphoma|
|Relapsed/Refractory EBV+ Solid Tumors|
|Other Virus-associated Malignancies|
|Relapsed/Refractory EBV+ Lymphoma||Late-Stage Clinical|
|Relapsed/Refractory EBV+ Solid Tumors||Early-Stage Clinical|
|Other Virus-associated Malignancies||Preclinical|
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for nanatinostat in combination with valganciclovir for the treatment of relapsed/refractory Epstein-Barr virus (EBV)-positive lymphoid malignancies.
- Orphan Drug Designations granted for nanatinostat with valganciclovir for the treatment of:
- T-cell lymphoma
- Post-transplant lymphoproliferative disorder (PTLD)
- Plasmablastic lymphoma
Viracta has an Expanded Access Policy in compliance with the 21st Century Cures Act.