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FDA Extends Exelixis Drug Review to March 2027
x/exelixis
— Sep 11, 2026
The FDA has extended Exelixis' NDA review for zanzalintinib in combination with atezolizumab/Tecentriq for metastatic colorectal cancer by three months, moving the action date to March 3, 2027 after updated safety and efficacy data were deemed a major amendment. The development of zanzalintinib as a next-generation cancer therapy continues, with the delay potentially impacting timelines for patients, investors, and partners awaiting a decision.
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Nicole Hardy
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.
