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NOV 27 2026
UPCOMING · 177 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 (NSCLC) is the most common form of lung cancer, often resistant to chemotherapy and typically treated with surgery when possible. Neladalkib is a targeted drug that blocks the ALK protein—a key driver of tumor growth—while also reaching cancer cells in the brain. By precisely inhibiting ALK throughout the body, this drug could help slow disease progression in patients whose tumors have stopped responding to earlier treatments.

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