# JIDEYTRO (zidesamtinib) PDUFA Event: ROS1-positive non-small cell lung cancer

Canonical URL: https://biopharmsignal.com/pdufa-calendar/NUVL/zidesamtinib-ros1-positive-nsclc

Ticker: NUVL

Company: Nuvalent

Event date: 2026-09-18

Event type: FDA Decision

Stage: PDUFA

Result: Approved

Result date: 2026-07-22

Application type: NDA

FDA approved JIDEYTRO. FDA approved JIDEYTRO for adults with locally advanced or metastatic ROS1-positive NSCLC after at least one prior ROS1 TKI. The action...

## Event Timeline

### July 22, 2026 — FDA approved JIDEYTRO

FDA approved JIDEYTRO for adults with locally advanced or metastatic ROS1-positive NSCLC after at least one prior ROS1 TKI. The action occurred before the September 18 PDUFA date.

[FDA — Approval of zidesamtinib](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer)

### November 19, 2025 — FDA accepted the NDA

FDA accepted the zidesamtinib NDA for TKI-pretreated advanced ROS1-positive NSCLC and assigned a September 18, 2026 PDUFA target action date.

[Nuvalent — FDA acceptance of the zidesamtinib NDA](https://investors.nuvalent.com/2025-11-19-Nuvalent-Announces-FDA-Acceptance-of-New-Drug-Application-for-Zidesamtinib-for-the-Treatment-of-TKI-Pre-treated-Patients-with-Advanced-ROS1-positive-NSCLC)

### September 8, 2025 — Pivotal ARROS-1 data were presented

Nuvalent presented the registrational ARROS-1 efficacy and safety data for zidesamtinib in TKI-pretreated advanced ROS1-positive NSCLC at the World Conference on Lung Cancer.

[Nuvalent — Pivotal ARROS-1 presentation](https://investors.nuvalent.com/2025-08-13-Nuvalent-to-Present-Pivotal-Data-from-ARROS-1-Clinical-Trial-of-Zidesamtinib-for-TKI-Pre-treated-Patients-with-Advanced-ROS1-positive-NSCLC-at-WCLC-2025-Presidential-Symposium?asPDF=1)

### January 4, 2022 — Phase 1/2 ARROS-1 study started

ARROS-1 began enrolling patients with ROS1-positive advanced solid tumors to characterize zidesamtinib activity and safety, generating the pivotal cohort used for the NDA.

[ClinicalTrials.gov — ARROS-1 study record (NCT05118789)](https://clinicaltrials.gov/study/NCT05118789)

## Regulatory Designations

- Breakthrough Therapy FDA: [Nuvalent — Zidesamtinib designations and pivotal-data plans](https://investors.nuvalent.com/2025-08-13-Nuvalent-to-Present-Pivotal-Data-from-ARROS-1-Clinical-Trial-of-Zidesamtinib-for-TKI-Pre-treated-Patients-with-Advanced-ROS1-positive-NSCLC-at-WCLC-2025-Presidential-Symposium?asPDF=1)

- Orphan Drug FDA: [Nuvalent — Zidesamtinib designations and pivotal-data plans](https://investors.nuvalent.com/2025-08-13-Nuvalent-to-Present-Pivotal-Data-from-ARROS-1-Clinical-Trial-of-Zidesamtinib-for-TKI-Pre-treated-Patients-with-Advanced-ROS1-positive-NSCLC-at-WCLC-2025-Presidential-Symposium?asPDF=1)

## 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