Posted by Michael Wonder on 07 Apr 2026
Nuvalent announces submission of new drug application to FDA for neladalkib in TKI pre-treated advanced ALK positive NSCLC
7 April 2026 - New drug application based on data in TKI pre-treated patients from the global ALKOVE-1 Phase 1/2 clinical trial.
Nuvalent today announced the submission to the US FDA of the Company's new drug application for neladalkib, an investigational ALK selective inhibitor, in TKI pre-treated advanced ALK positive non-small-cell lung cancer.
