NOV 27 2026
Nuvalent — neladalkib $NUVL
for TKI-pretreated advanced ALK-positive non-small cell lung cancer
Accepted APR 7 2026.
About
Non-small cell lung cancer is the most common form of lung cancer and is often treated with surgery when possible. Neladalkib is a pill designed to block the ALK protein that drives some of these cancers, and it is built to reach tumors in the brain. For people whose cancer has progressed on prior ALK-targeting drugs, this approach may offer a new way to control the disease.
Pivotal trial
Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on neladalkib
- NUVL: Two major drug launches in 2024, with neladalkib poised to shift ALK treatment standards - TradingView
- Jessica J. Lin, MD, on Neladalkib in Advanced ALK-Positive NSCLC - The ASCO Post
- Neladalkib Earns FDA Priority Review in ALK-Positive NSCLC - CancerNetwork
- FDA Grants Priority Review to Neladalkib for TKI-Pretreated ALK+ NSCLC - OncLive
- FDA Grants Priority Review to Neladalkib NDA for ALK-Positive NSCLC - Targeted Oncology
Sponsor Watch — recent news on Nuvalent
- Nuvalent Announces Key Program and Business Updates, Strengthening Foundation for Global Leadership in ROS1- and ALK-positive NSCLC
- Nuvalent Highlights Upcoming Data Presentations for Neladalkib and Zidesamtinib at the 2026 American Society of Clinical Oncology Annual Meeting
- Nuvalent Highlights Recent Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2026 Financial Results
- Nuvalent (NUVL) Submits NDA to FDA for Neladalkib in ALK-Positive NSCLC
- Nuvalent to Present Pivotal Data from ALKOVE-1 Trial of Neladalkib in TKI Pre-treated Advanced ALK-positive NSCLC at the 2026 American Society of Clinical Oncology Annual Meeting