Nuvalent Inc. (NASDAQ: NUVL) submitted a New Drug Application to the U.S. Food and Drug Administration for neladalkib, an investigational ALK-selective inhibitor for treating advanced ALK-positive non-small cell lung cancer in patients previously treated with tyrosine kinase inhibitors.

The application is based on data from the ALKOVE-1 Phase 1/2 clinical trial, which tested neladalkib in patients with advanced ALK-positive NSCLC who had received prior TKI treatment. According to the company, neladalkib showed overall activity including intracranial responses and demonstrated a generally well-tolerated safety profile.

"The advancement of neladalkib from first clinical trial initiation to NDA submission in less than four years represents a remarkable pace in oncology drug development," said Darlene Noci, Chief Development Officer at Nuvalent.

Neladalkib has received breakthrough therapy designation from the FDA for treating patients with locally advanced or metastatic ALK-positive NSCLC who have been previously treated with two or more ALK tyrosine kinase inhibitors. The drug also received orphan drug designation for ALK-positive NSCLC.

Nuvalent plans to share detailed results from the ALKOVE-1 trial at a future medical meeting. The company stated it will work with the FDA throughout the review process.

The clinical-stage biopharmaceutical company focuses on developing targeted therapies for kinase targets in cancer treatment.