Exelixis Announces CELESTIAL Phase 3 Pivotal Trial Results Published in The New England Journal of Medicine

Exelixis (Nasdaq:EXEL) announced that The New England Journal of Medicine (NEJM) published results from the CELESTIAL phase 3 pivotal trial of cabozantinib in patients with previously treated advanced hepatocellular carcinoma (HCC).¹ The data, originally presented at the 2018 American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium (ASCO-GI) in January, demonstrate that cabozantinib provided a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo.

As quoted in the press release:

“Patients with this form of advanced liver cancer have very limited treatment options once their disease progresses following treatment with sorafenib,” said Ghassan K. Abou-Alfa, M.D., Memorial Sloan Kettering Cancer Center, New York and lead investigator on CELESTIAL. “These results suggest that, if approved, cabozantinib could become an important addition to the treatment landscape that may help slow disease progression and, critically, improve survival for these patients.”

Exelixis announced in May 2018 that the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental New Drug Application (sNDA) for CABOMETYX^® (cabozantinib) tablets as a treatment for patients with previously treated HCC. The filing has been assigned a Prescription Drug User Fee Act action date of January 14, 2019. Exelixis’ partner Ipsen received validation by the European Medicines Agency in March 2018 for its application for variation to the CABOMETYX marketing authorization to include the new indication for patients with previously treated advanced HCC.’

Click here to read the full press release.