Despite Government Shutdown, Exelixis Snags FDA Approval for HCC Drug Cabometyx

Shares of Alameda, Calif.-based Exelixis are climbing after the U.S. Food and Drug Administration (FDA) approved its hepatocellular carcinoma (HCC) treatment Cabometyx (cabozantinib). It was previously approved for the treatment of patients with advanced renal cell carcinoma. The approval came despite a partial government shutdown that will likely delay a number of potential approvals unless funding is restored to the regulatory agency. Exelixis’ Cabometyx was approved for HCC patients who have been previously treated with the chemotherapy drug sorafenib.
The FDA approved Cabometyx based on the Phase III CELESTIAL trial. Cabometyx targets MET, AXL and VEGFR-1, -2 and -3. Phase III data showed Cabometyx provided a statistically significant and clinically meaningful improvement in median overall survival compared to placebo in patients with advanced HCC. Median overall survival was 10.2 months with Cabometyx versus 8 months with placebo. Median progression-free survival was more than doubled, at 5.2 months with Cabometyx and 1.9 months with placebo. Following an interim analysis in 2017, the Phase III CELESTIAL trial was halted early due to achieving efficacy.