Shots:
- The US FDA has accepted NDA of zanzalintinib + Tecentriq (atezolizumab) for the treatment of adults with mCRC who have been previously treated with fluoropyrimidine, oxaliplatin & irinotecan-based CT, &, if RAS wild-type, an anti-EGFR therapy (PDUFA: Dec 03, 2026)
- NDA was based on P-III (STELLAR-303) trial assessing zanzalintinib in combination with atezolizumab (n=451) or regorafenib (n=450) in pts with previously treated non-MSI-high mCRC
- Trial improved OS in the ITT population with previously treated CRC, with full OS & PFS data, overall & in patients without liver metastases, presented at ESMO’25 & published in The Lancet. Data for the other co-1EP, OS in pts without active liver metastases, were immature, with final analysis expected in mid-2026
Ref: Exelixis | Image: Exelixis | Press Release
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