# Zipalertinib (CLN-081/TAS6417) PDUFA Event: Locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations

Canonical URL: https://biopharmsignal.com/pdufa-calendar/CGEM/zipalertinib-egfr-exon-20-insertion-nsclc

Ticker: CGEM

Company: Cullinan Therapeutics, Inc.

Event date: 2027-02-27

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: NDA

FDA decision expected. FDA set February 27, 2027 as the PDUFA target action date for the zipalertinib NDA.

## Event Timeline

### February 27, 2027 — FDA decision expected

FDA set February 27, 2027 as the PDUFA target action date for the zipalertinib NDA.

[Taiho Oncology and Cullinan — NDA acceptance and PDUFA date](https://investors.cullinantherapeutics.com/node/10006/pdf)

### April 28, 2026 — FDA accepted the NDA for review

FDA accepted the NDA for zipalertinib in previously treated EGFR exon 20 insertion-positive non-small cell lung cancer.

[Taiho Oncology and Cullinan — FDA acceptance](https://investors.cullinantherapeutics.com/node/10006/pdf)

### April 28, 2026 — REZILIENT1 data supported the filing

The NDA was based on the pivotal Phase 2b REZILIENT1 study, which reported clinically meaningful and durable responses in relapsed EGFR exon 20 insertion-mutated non-small cell lung cancer.

[Taiho Oncology and Cullinan — REZILIENT1 filing support](https://investors.cullinantherapeutics.com/node/10006/pdf)

## Related Pages

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

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

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

## Related News

- 2026-10-08 — Cullinan Therapeutics Announces First Patient Dosed in Planned Registrational Phase 2 Study of CLN-049 in Relapsed/Refractory Acute Myeloid Leukemia: https://biopharmsignal.com/news/CGEM/cullinan-therapeutics-announces-first-patient-dosed-in-planned-registrational-ph-99d22b39.md

- 2026-10-01 — New Drug Application Submission Initiated for Zipalertinib Plus Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation NSCLC for Review Under FDA Real-Time Oncology Review Program: https://biopharmsignal.com/news/CGEM/new-drug-application-submission-initiated-for-zipalertinib-plus-chemotherapy-in--183e621e.md

- 2026-09-24 — Cullinan Therapeutics Highlights Fourth Quarter 2026 Milestones Across Immunology and Oncology T Cell Engager Portfolio: https://biopharmsignal.com/news/CGEM/cullinan-therapeutics-highlights-fourth-quarter-2026-milestones-across-immunolog-bd689ea1.md

- 2026-09-21 — Cullinan Therapeutics to Participate in the Stifel 2026 Virtual Immunology and Inflammation Forum: https://biopharmsignal.com/news/CGEM/cullinan-therapeutics-to-participate-in-the-stifel-2026-virtual-immunology-and-i-ea0af110.md

- 2026-09-14 — Cullinan Therapeutics to Host Virtual Analyst and Investor Event Today to Feature Zipalertinib Plus Chemotherapy Phase 3 REZILIENT3 Data Presented at the IASLC 2026 World Conference on Lung Cancer: https://biopharmsignal.com/news/CGEM/cullinan-therapeutics-to-host-virtual-analyst-and-investor-event-today-to-featur-36a3bb44.md