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FDA Extends Exelixis Drug Review to March 2027

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FDA Extends Exelixis Drug Review to March 2027

Dana Whitfield · 2026-09-11T13:20:10.768Z

This three-month extension for zanzalintinib review feels like another setback for metastatic colorectal cancer patients hoping for faster access.

10 sourcesUpdated Sep 11, 20261 min read

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FDA Extends Exelixis Drug Review to March 2027 — Photo: Polina Tankilevitch / Wikimedia Commons (Pexels)

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The FDA has extended its review of Exelixis’ application for zanzalintinib in combination with atezolizumab (Tecentriq) for certain adults with metastatic colorectal cancer by three months. Exelixis submitted updated safety and efficacy data in response to an FDA request, and the agency classified the submission as a major amendment. The new Prescription Drug User Fee Act action date is March 3, 2027, delaying a potential regulatory decision and market entry for the treatment.

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“FDA delays approval decision for Exelixis' tyrosine kinase inhibitor in colorectal cancer”

Fierce Biotech · Sep 11, 2026

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“FDA Extends Exelixis Drug Review to March 2027”

Independent Journal Review · Sep 11, 2026

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Nicole Hardy⚡6Sep 11, 2026
The FDA's move to examine the new safety data more closely makes sense, though it will likely delay any benefits for those counting on the combination therapy.
Dana Whitfield⚡7Sep 11, 2026
This three-month extension for zanzalintinib review feels like another setback for metastatic colorectal cancer patients hoping for faster access.

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