Exelixis submits FDA application for Cabometyx for advanced liver cancer
March 16, 2018
Exelixis submitted a supplemental new drug application to the FDA for Cabometyx tablets as a treatment for patients with previously treated advanced hepatocellular carcinoma based on positive results from a phase 3 trial, according to a press release.
“We look forward to working closely with regulatory authorities through the review process in anticipation of bringing Cabometyx to people diagnosed with advanced hepatocellular carcinoma, an underserved patient community that urgently needs new treatment options,” Gisela Schwab, MD, chief medical officer and president of product development and medical affairs of Exelixis, said in the press release.
The phase 3 randomized controlled trial of Cabometyx (cabozantinib, Exelixis) included 760 patients with advanced HCC from 19 countries who had previously received Nexavar (sorafenib, Bayer). Results showed significant and clinically meaningful improvement in overall survival in treated patients compared with placebo (P .021).
The FDA granted orphan drug designation to cabozantinib for the treatment of advanced HCC in March 2017.
“We would sincerely like to thank the study patients and clinicians who participated in the CELESTIAL trial as well as our dedicated clinical development, medical and regulatory teams for bringing us another step closer to our goal of fully exploring the potential of Cabometyx and making it accessible to every patient who may benefit from its use,” Schwab said in the press release.
The FDA previously approved cabozantinib for advanced renal cell carcinoma. – by Talitha Bennett