In April 2026, Nuvalent announced the submission of a New Drug Application (NDA) for NVL-655 (neladalkib), its investigational next-generation ALK inhibitor for previously treated ALK-positive non-small cell lung cancer (NSCLC). The filing was based on data from the ongoing ALKOVE-1 clinical trial and represents an important potential new treatment option for patients whose cancer has progressed after prior ALK-targeted therapies.
When a biotech company files an NDA with the U.S. Food and Drug Administration (FDA), it is formally seeking approval to make a new medicine available in the United States. The FDA then conducts an extensive review of the drug’s safety, effectiveness, side effects, manufacturing quality, and prescribing information. Within approximately 60 days, the FDA decides whether to accept the application for review and assigns a target decision deadline known as the PDUFA date (Prescription Drug User Fee Act date). By that date, the FDA may approve the drug, request additional information, or issue a Complete Response Letter outlining concerns that must be addressed.
For patients and advocacy groups, an NDA filing marks a major milestone, signaling that the therapy has completed clinical testing and entered the final stage of regulatory review before potential approval. As of May 2026, the FDA had not yet publicly announced a PDUFA date for NVL-655.
Read the full press release here:
Nuvalent Announces Submission of New Drug Application to FDA for Neladalkib
To learn more about NVL-655, the ALKOVE-1 clinical trial, and patient perspectives on this developing treatment option, read Jeff’s detailed overview here:
ALKOVE-1 Trial: NVL-655 in Advanced ALK-Positive Cancers
