Reported about 18 hours ago
Nuvalent Inc. has announced positive pivotal results from its ARROS-1 Phase 1/2 trial for zidesamtinib, a new treatment for patients with advanced ROS1-positive non-small cell lung cancer. The FDA has agreed to consider an NDA submission under its Real-Time Oncology Review program, allowing for accelerated evaluation. A rolling NDA submission is planned for July, with hopes to complete it by Q3 2025.
Source: YAHOO