# Zanzalintinib (XL092) + atezolizumab PDUFA Event: Previously treated metastatic colorectal cancer

Canonical URL: https://biopharmsignal.com/pdufa-calendar/EXEL/zanzalintinib-atezolizumab-pretreated-metastatic-crc

Ticker: EXEL

Company: Exelixis

Event date: 2026-12-03

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: NDA

FDA decision expected. FDA assigned a December 3, 2026 PDUFA target action date to the zanzalintinib plus atezolizumab NDA under standard review.

## Event Timeline

### December 3, 2026 — FDA decision expected

FDA assigned a December 3, 2026 PDUFA target action date to the zanzalintinib plus atezolizumab NDA under standard review.

[Exelixis — NDA acceptance and PDUFA date](https://ir.exelixis.com/node/27136)

### February 2, 2026 — FDA accepted the NDA for review

FDA accepted the application based on the Phase 3 STELLAR-303 trial in previously treated metastatic colorectal cancer.

[Exelixis — NDA acceptance](https://ir.exelixis.com/node/27136)

### October 20, 2025 — Detailed STELLAR-303 results were presented and published

Zanzalintinib plus atezolizumab improved median overall survival to 10.9 months from 9.4 months with regorafenib and reduced the risk of death by 20% in the intention-to-treat population.

[Exelixis — Detailed Phase 3 STELLAR-303 results](https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-detailed-results-phase-3-stellar-303-pivotal)

### September 7, 2022 — Phase 3 STELLAR-303 started

The randomized Phase 3 trial began evaluating zanzalintinib plus atezolizumab against regorafenib in previously treated metastatic colorectal cancer.

[ClinicalTrials.gov — STELLAR-303 study record](https://clinicaltrials.gov/study/NCT05425940)

## Related Pages

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

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

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

## Related News

- 2026-09-01 — Exelixis to Webcast Fireside Chats as Part of Upcoming Investor Conferences in September: https://biopharmsignal.com/news/EXEL/exelixis-to-webcast-fireside-chats-as-part-of-upcoming-investor-conferences-in-s-d8eb9815.md

- 2026-08-31 — Exelixis Announces Update on Patent Litigation Trial Appeal with MSN Laboratories: https://biopharmsignal.com/news/EXEL/exelixis-announces-update-on-patent-litigation-trial-appeal-with-msn-laboratorie-405d9e66.md

- 2026-08-05 — Exelixis Announces Second Quarter 2026 Financial Results and Provides Corporate Update: https://biopharmsignal.com/news/EXEL/exelixis-announces-second-quarter-2026-financial-results-and-provides-corporate--778a8828.md

- 2026-07-22 — Exelixis to Release Second Quarter 2026 Financial Results on Wednesday, August 5, 2026: https://biopharmsignal.com/news/EXEL/exelixis-to-release-second-quarter-2026-financial-results-on-wednesday-august-5--57b00d9c.md

- 2026-06-22 — Exelixis Provides Update on the Phase 3 STELLAR-303 Trial Evaluating Zanzalintinib in Combination with an Immune Checkpoint Inhibitor in Patients with Metastatic Colorectal Cancer: https://biopharmsignal.com/news/EXEL/exelixis-provides-update-on-the-phase-3-stellar-303-trial-evaluating-zanzalintin-de926b13.md