Regorafenib (Stivarga) approval (2012)
The FDA approved regorafenib as the first treatment for metastatic colorectal cancer that had progressed after standard therapy. Approval rested on the CORRECT trial, where the drug extended median overall survival from 5.0 to 6.4 months.
Regorafenib became the standard third-line option and remains one today.
It set the benchmark for late-line colon cancer drugs and is the comparator arm in Exelixis' STELLAR-303 trial.
Zanzalintinib was tested directly against regorafenib, and the 1.5-month median survival advantage it showed echoes the modest benefits the FDA has accepted in this exact setting.
