Saturday, 24 August 2019

Exelixis announces USFDA approval of CABOMETYX

16 January 2019 | News

HCC is the most common form of liver cancer and the fastest-rising cause of cancer-related death in the U.S.

Oncology focused biotechnology company, Exelixis has announced that USFDA has approved CABOMETYX tablets for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

HCC is the most common form of liver cancer and the fastest-rising cause of cancer-related death in the U.S.

Michael M. Morrissey, President and Chief Executive Officer of Exelixis said, “This new indication for CABOMETYX is an important treatment advance for patients with this aggressive form of liver cancer, a community in need of new therapeutic options. This approval is an important milestone as we continue to explore how CABOMETYX may benefit people with difficult-to-treat-cancers beyond renal cell carcinoma. We would like to thank the patients and clinicians who participated in CELESTIAL and to acknowledge the team at the FDA for their continued collaboration during the review of our application.”

The FDA’s approval of CABOMETYX was based on results from the CELESTIAL phase 3 pivotal trial of CABOMETYX for patients with advanced HCC who received prior sorafenib. CABOMETYX demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo.

 

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