Posted by Michael Wonder on 24 Dec 2024
US FDA accepts for priority review Nuvation Bio’s new drug application for taletrectinib for the treatment of advanced ROS1 positive non-small cell lung cancer
23 December 2024 - New drug application is based on pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib that demonstrated durable responses and prolonged progression-free survival in patients with advanced ROS1 positive non-small cell lung cancer.
Nuvation Bio today announced that the US FDA has accepted the company’s NDA for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor, for the treatment of advanced ROS1 positive non-small cell lung cancer (line agnostic).
