The Food and Drug Administration granted accelerated approval on August 6 to Tudriqev, an injected virus-based immunotherapy, in combination with nivolumab for adults whose unresectable advanced cutaneous melanoma has progressed on a PD-1 blocking antibody-based regimen. The decision reverses two prior rejections and gives patients in one of oncology's most difficult positions a new option while a confirmatory trial runs.
The population this reaches is specific and currently underserved. About half of melanoma patients do not respond to checkpoint blockade or progress after it, and more than half of patients treated with checkpoint inhibitors progress within six months. Median overall survival after that progression is under one year.
