Upcoming FDA decision · March 3, 2027
Zanzalintinib PDUFA date: FDA decision expected March 3, 2027
138 days to goExelixis, Inc. (EXEL) →
The FDA is expected to decide on Zanzalintinib from Exelixis, Inc. in Previously treated metastatic colorectal cancer (with atezolizumab) by the PDUFA target action date of March 3, 2027. For previously treated metastatic colorectal cancer, with atezolizumab. NDA; goal date extended three months from December 3, 2026 after a major amendment. Verified 2026-10-16.
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: cancernetwork.com · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
March 3
Target action date
Phase 3
Stage
Verified
Date confidence
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FDA designations
Questions about this FDA decision
- When is the PDUFA date for Zanzalintinib?
- The FDA's PDUFA target action date for Zanzalintinib is March 3, 2027. The FDA can act before that date, and the review can be extended.
- What is Zanzalintinib being reviewed for?
- The application under FDA review covers Previously treated metastatic colorectal cancer (with atezolizumab).
- Which company is developing Zanzalintinib?
- Exelixis, Inc. (EXEL).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).