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NOV 27 2026
UPCOMING · 59 DAYS TO PDUFA

Nuvalent — neladalkib $NUVL

for TKI-pretreated advanced ALK-positive non-small cell lung cancer

NDA · Priority Review

Accepted APR 7 2026.

About

Non-small-cell lung cancer is the most common form of lung cancer, accounting for about 85% of cases, and it tends to respond poorly to chemotherapy, so surgery is usually the preferred treatment when the disease is caught early. Neladalkib is an oral medicine that selectively blocks ALK, a protein that drives cancer growth in some lung tumors, and it is designed to reach the brain as well. Because ALK-positive tumors depend on that protein to grow, blocking it may slow or stop the cancer—including cancer that has spread to the brain—though the benefit is still being confirmed.

Pivotal trial

ALKAZAR Phase 3 recruiting NCT06765109

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