Nuvalent Submits NDA to FDA for Neladalkib to Treat ALK-Positive NSCLC After Prior TKI Therapy

Nuvalent has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational therapy, neladalkib. The application seeks approval for the use of neladalkib in treating patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have previously undergone treatment with tyrosine kinase inhibitors (TKIs). This submission marks a significant step in the development process for the targeted therapy.

The NDA is based on clinical data from studies evaluating neladalkib’s safety, efficacy, and tolerability in individuals with advanced ALK-positive NSCLC who experienced disease progression following prior TKI treatments. Nuvalent aims to address unmet medical needs within this patient population by offering an alternative therapeutic option. The FDA will review the application to determine whether neladalkib meets regulatory standards for approval as a treatment option in this specific setting.

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Date: April 7, 2026

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GOAI