Nuvalent submits NDA for neladalkib and advances zidesamtinib FDA review for lung cancer treatments

Nuvalent has submitted a New Drug Application (NDA) for neladalkib targeting ALK-positive non-small cell lung cancer (NSCLC) patients previously treated with tyrosine kinase inhibitors (TKIs). Meanwhile, the FDA is reviewing the NDA for zidesamtinib, aimed at ROS1-positive NSCLC, with a decision expected by September 18, 2026. The company is preparing for a potential U.S. launch of zidesamtinib and plans to seek label expansion for earlier-stage patients later in 2026. These developments mark key steps toward bringing new targeted therapies to lung cancer patients, supported by strong clinical data and ongoing trials.