Neladalkib
A fourth-generation ALK pill that works after lorlatinib and avoids the TRK-related brain side effects; under FDA priority review with a decision due 27 November 2026.
Nuvalent's ALK-selective, TRK-sparing, brain-penetrant inhibitor covering G1202R and compound mutations. ALKOVE-1: ORR 31% in heavily TKI-pretreated patients (n=253) with intracranial activity. NDA submitted April 2026 (priority review, PDUFA 27 Nov 2026). ALKAZAR phase 3 vs alectinib first line recruiting.
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Trials
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Landmark trials in OnCo
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topQuery for this drug: (TITLE:"Neladalkib" OR ABSTRACT:"Neladalkib" OR TITLE:"NVL-655" OR ABSTRACT:"NVL-655") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Neladalkib, not a curated reading list.
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