# Neladalkib

Source: https://onco.cc/drugs/neladalkib/  
OnCo record `neladalkib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-06
- 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.

## Sources

- OncLive: priority review: https://www.onclive.com/view/fda-grants-priority-review-to-neladalkib-for-tki-pretreated-alk-nsclc

## Connected records

- cancers: [ALK-positive non-small-cell lung cancer](https://onco.cc/cancers/alk-positive-nsclc/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [ALK](https://onco.cc/targets/alk/)
- drugs: [Alectinib](https://onco.cc/drugs/alectinib/), [Lorlatinib](https://onco.cc/drugs/lorlatinib/)
- companies: [Nuvalent](https://onco.cc/companies/nuvalent/)
- trials: [ALKOVE-1](https://onco.cc/trials/alkove-1/), [Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC](https://onco.cc/trials/nct06765109/)
- roadmaps: [Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall](https://onco.cc/roadmaps/targeted-therapy-roadmap/)

---
JSON: https://onco.cc/api/v1/entities/neladalkib.json