{"entity":{"id":"neladalkib","kind":"drug","name":"Neladalkib","aka":[],"tldr":"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.","summary":"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.","status":"phase-3","asOf":"2026-09-06","links":[{"label":"OncLive: priority review","url":"https://www.onclive.com/view/fda-grants-priority-review-to-neladalkib-for-tki-pretreated-alk-nsclc"}],"tags":[],"related":[],"cancers":["nsclc","alk-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["alk"],"drugs":["lorlatinib","alectinib"],"companies":["nuvalent"],"institutions":[],"pathways":[],"terms":[],"trials":["alkove-1","nct06765109"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"code":"NVL-655","modality":"Small-molecule kinase inhibitor (ALK)","mechanism":"ALK-selective TKI designed to avoid TRK inhibition (dizziness, weight gain) and cover solvent-front and compound mutations.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/neladalkib/","neighbours":{"cancer":[{"id":"alk-positive-nsclc","kind":"cancer","name":"ALK-positive non-small-cell lung cancer","route":"/cancers/alk-positive-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"alk","kind":"target","name":"ALK","route":"/targets/alk/"}],"drug":[{"id":"alectinib","kind":"drug","name":"Alectinib","route":"/drugs/alectinib/"},{"id":"lorlatinib","kind":"drug","name":"Lorlatinib","route":"/drugs/lorlatinib/"}],"company":[{"id":"nuvalent","kind":"company","name":"Nuvalent","route":"/companies/nuvalent/"}],"trial":[{"id":"alkove-1","kind":"trial","name":"ALKOVE-1","route":"/trials/alkove-1/"},{"id":"nct06765109","kind":"trial","name":"Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC","route":"/trials/nct06765109/"}],"roadmap":[{"id":"targeted-therapy-roadmap","kind":"roadmap","name":"Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall","route":"/roadmaps/targeted-therapy-roadmap/"}]}}