Neladalkib Earns FDA Priority Review in ALK-Positive NSCLC
The U.S. Food and Drug Administration has granted priority review for neladalkib as a treatment for patients with advanced ALK‑positive non‑small cell lung cancer (NSCLC) who have previously received tyrosine kinase inhibitors (TKIs).
The FDA has granted priority review to neladalkib for ALK‑positive NSCLC patients who progressed on prior TKIs. Phase 1/2 ALKOVE‑1 trial data (NCT05384626) showed an overall response rate (ORR) of 31% in 253 patients and 46% in 63 lorlatinib‑naïve patients; durable responses were observed at 6, 12, and 18 months. Intracranial ORR was 32% in 92 CNS‑lesion patients, rising to 63% in 24 lorlatinib‑naïve CNS‑lesion patients. Common grade‑any toxicities included transaminase elevations, constipation, dysgeusia, peripheral edema, cough, and nausea.
This priority review enables a faster pathway toward an FDA‑approved therapy for patients with ALK‑positive NSCLC who have exhausted standard TKI options, including those with brain metastases, offering a prospectively improved response and durable control with a manageable safety profile.
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