Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib for the Treatment of TKI Pre-treated Patients with Advanced ROS1-positive NSCLC

Core Viewpoint - Nuvalent, Inc. has submitted a New Drug Application (NDA) for zidesamtinib, a ROS1-selective inhibitor, to the FDA for treating adult patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) who have previously received at least one ROS1 tyrosine kinase inhibitor (TKI) [1][2] Group 1: Zidesamtinib and Clinical Trials - Zidesamtinib is designed to overcome limitations of existing ROS1 inhibitors and is effective against tumors with treatment-emergent ROS1 mutations, such as G2032R [3][4] - The ARROS-1 Phase 1/2 clinical trial is investigating zidesamtinib in patients with advanced ROS1-positive NSCLC and other solid tumors, focusing on safety, tolerability, and preliminary anti-tumor activity [4] - The FDA has assigned a PDUFA target action date of September 18, 2026, for the NDA submission [1] Group 2: Company Overview - Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on developing targeted therapies for cancer, leveraging expertise in chemistry and structure-based drug design [5] - The company is advancing a pipeline that includes investigational candidates for ROS1-positive, ALK-positive, and HER2-altered NSCLC, along with multiple discovery-stage research programs [5]