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pdufa.bio

Zanzalintinib

Updated ยทnext FDA decision on the calendar

Zanzalintinib is a Exelixis program in 2L metastatic colorectal cancer. Its PDUFA date is Dec 3, 2026, the FDA's goal date to complete review of the application. Every date links its source.

EXEL catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: 2L metastatic colorectal cancer. Sponsor: Exelixis (EXEL). Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Dec 3, 2026EXEL

Questions

When is Zanzalintinib's next FDA decision or readout?

Zanzalintinib's PDUFA date is Dec 3, 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.

What happened at Zanzalintinib's most recent FDA decision?

No FDA decision for Zanzalintinib is in our archive yet.

What is Zanzalintinib used for?

In our records Zanzalintinib is under review or in development for 2L metastatic colorectal cancer.

Who makes Zanzalintinib?

Exelixis (EXEL).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.