# Neladalkib (NVL-655) PDUFA Event: TKI-pretreated advanced ALK-positive non-small cell lung cancer

Canonical URL: https://biopharmsignal.com/pdufa-calendar/NUVL/neladalkib-tki-pretreated-alk-positive-nsclc

Ticker: NUVL

Company: Nuvalent

Event date: 2026-11-27

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: NDA

FDA decision expected. FDA assigned a November 27, 2026 PDUFA target action date to the neladalkib NDA.

## Event Timeline

### November 27, 2026 — FDA decision expected

FDA assigned a November 27, 2026 PDUFA target action date to the neladalkib NDA.

[Nuvalent — NDA acceptance and PDUFA date](https://investors.nuvalent.com/2026-05-27-Nuvalent-Announces-Key-Program-and-Business-Updates%2C-Strengthening-Foundation-for-Global-Leadership-in-ROS1-and-ALK-positive-NSCLC)

### May 27, 2026 — FDA accepted the NDA with Priority Review

FDA accepted the application based on the registration-directed ALKOVE-1 Phase 1/2 trial in TKI-pretreated advanced ALK-positive NSCLC.

[Nuvalent — NDA acceptance and Priority Review](https://investors.nuvalent.com/2026-05-27-Nuvalent-Announces-Key-Program-and-Business-Updates%2C-Strengthening-Foundation-for-Global-Leadership-in-ROS1-and-ALK-positive-NSCLC)

### November 17, 2025 — Positive pivotal ALKOVE-1 data were reported

Among 253 TKI-pretreated patients, the blinded independent central review objective response rate was 31%, with intracranial activity and durable responses reported.

[Nuvalent — Positive pivotal ALKOVE-1 data](https://investors.nuvalent.com/2025-11-17-Nuvalent-Announces-Positive-Topline-Pivotal-Data-from-ALKOVE-1-Clinical-Trial-of-Neladalkib-for-TKI-Pre-treated-Patients-with-Advanced-ALK-positive-NSCLC)

### June 9, 2022 — Phase 1/2 ALKOVE-1 study started

ALKOVE-1 began evaluating neladalkib in patients with advanced ALK-positive non-small-cell lung cancer and other ALK-driven solid tumors, including the pivotal TKI-pretreated cohort.

[ClinicalTrials.gov — ALKOVE-1 study record (NCT05384626)](https://clinicaltrials.gov/study/NCT05384626)

## Regulatory Designations

- Priority Review FDA: [Nuvalent — NDA acceptance and Priority Review](https://investors.nuvalent.com/2026-05-27-Nuvalent-Announces-Key-Program-and-Business-Updates%2C-Strengthening-Foundation-for-Global-Leadership-in-ROS1-and-ALK-positive-NSCLC)

- Breakthrough Therapy FDA: [Nuvalent — Neladalkib designations and pivotal data](https://investors.nuvalent.com/2025-11-17-Nuvalent-Announces-Positive-Topline-Pivotal-Data-from-ALKOVE-1-Clinical-Trial-of-Neladalkib-for-TKI-Pre-treated-Patients-with-Advanced-ALK-positive-NSCLC)

- Orphan Drug FDA: [Nuvalent — Neladalkib designations and pivotal data](https://investors.nuvalent.com/2025-11-17-Nuvalent-Announces-Positive-Topline-Pivotal-Data-from-ALKOVE-1-Clinical-Trial-of-Neladalkib-for-TKI-Pre-treated-Patients-with-Advanced-ALK-positive-NSCLC)

## Related Pages

- NUVL PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/NUVL.md

- NUVL company profile: https://biopharmsignal.com/company/NUVL.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md