Exelixis’ Cabometyx approved in second-line liver cancer in US

Exelixis’ cancer drug Cabometyx has been approved in a new liver cancer use in the US, providing a second line therapy option for patients previously treated with Bayer’s Nexavar. The FDA has approved Cabometyx (cabozantinib) for patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar (sorafenib). HCC is the most common form of liver cancer and the fastest rising cause of cancer-related death in the US, the company noted. Approval was based on results from the CELESTIAL phase 3 pivotal trial for patients with advanced HCC previously treated with Nexavar (sorafenib).
In the trial, median overall survival was 10.2 months with Cabometyx, compared with eight months in patients treated with placebo. Median progression-free survival more than doubled, at 5.2 months with Cabometyx compared with 1.9 months with placebo. In October 2017, Exelixis announced that the independent data monitoring committee for the CELESTIAL study recommended that the trial is stopped for efficacy following review at the second planned interim analysis because of the strong survival signal.