Nuvalent Initiates Rolling NDA Submission for Zidesamtinib in TKI Pre-Treated Advanced ROS1-Positive NSCLC Under FDA's RTOR Program

Nuvalent has presented pivotal data from the ARROS-1 clinical trial of zidesamtinib for TKI pre-treated patients with advanced ROS1-positive NSCLC at WCLC 2025. The company has initiated a rolling NDA submission for zidesamtinib under the FDA's RTOR program, with completion on track for Q3 2025. The data highlight the potential of zidesamtinib to deliver meaningful outcomes with a safe and well-tolerated safety profile, aiming to offer a new standard of care for this patient community.

Nuvalent, Inc. (Nasdaq: NUVL) has presented pivotal data from the ARROS-1 clinical trial of zidesamtinib for TKI pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) at the World Conference on Lung Cancer (WCLC 2025). The company has initiated a rolling New Drug Application (NDA) submission for zidesamtinib under the FDA's Real-Time Oncology Review (RTOR) program, with completion on track for the third quarter of 2025.

The data presented highlight the potential of zidesamtinib to deliver meaningful outcomes with a safe and well-tolerated safety profile. The drug is designed to overcome limitations observed with currently available ROS1 inhibitors, including resistance mutations and brain metastases. Zidesamtinib is a novel brain-penetrant ROS1-selective inhibitor that aims to provide a new standard of care for patients with ROS1-positive NSCLC [1].

Nuvalent's Chief Medical Officer, Christopher Turner, M.D., stated that there is a clear need for new treatment options for patients with ROS1-positive NSCLC, particularly those who are unable to tolerate the currently available TKIs or whose disease progresses with brain metastases or resistance mutations. The data presented at WCLC 2025 represent important progress toward offering a new standard of care for this patient community [1].

Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ROS1 tyrosine kinase inhibitors and orphan drug designation for ROS1-positive NSCLC. It is currently being investigated in the ARROS-1 trial, a first-in-human Phase 1/2 clinical trial for patients with advanced ROS1-positive NSCLC and other solid tumors [1].

Nuvalent is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer. The company's pipeline includes investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs [1].

References:

[1] https://www.prnewswire.com/news-releases/nuvalent-presents-pivotal-data-from-arros-1-clinical-trial-of-zidesamtinib-for-tki-pre-treated-patients-with-advanced-ros1-positive-nsclc-at-wclc-2025-302548220.html