FDA accepts supplemental NDA for taletrectinib targeting ROS1‑positive lung cancer

The U.S. Food and Drug Administration has accepted a supplemental New Drug Application for taletrectinib, a targeted therapy aimed at patients with ROS1‑positive non‑small cell lung cancer.

The filing presents updated clinical data that include both treatment‑naive patients and those who have previously received tyrosine kinase inhibitors for advanced disease.

Regulatory acceptance moves the product toward a formal review that could broaden its approved use for advanced ROS1‑positive NSCLC.