New Clinical and Preclinical Data for Investigational Candidate Zidesamtinib Presented at AACR Annual Meeting 2026
This image was generated by AI and may not depict real events.
Nuvalent presented new clinical and preclinical data for zidesamtinib, an investigational ROS1-selective inhibitor, at the AACR Annual Meeting 2026. The data showed meaningful clinical activity in patients with ROS1-positive NSCLC previously treated with other TKIs.
Nuvalent, a biopharmaceutical company, presented new data on zidesamtinib at the AACR Annual Meeting 2026. Zidesamtinib demonstrated clinical activity in patients with ROS1-positive NSCLC who had been previously treated with repotrectinib or taletrectinib. The data included activity in tumors with the ROS1 G2032R resistance mutation and intracranial complete responses in patients with CNS disease. The FDA has accepted Nuvalent's New Drug Application for zidesamtinib with a target action date of September 18, 2026. Nuvalent anticipates a US commercial launch in 2026 pending FDA review. The company plans to submit additional data to support a potential label expansion in TKI-naïve patients.
This content was automatically generated and/or translated by AI. It may contain inaccuracies. Please refer to the original sources for verification.