January 14, 2019--Alameda, CA--(BUSINESS WIRE)
Exelixis, Inc. (Nasdaq: EXEL) announced that the U.S. Food and Drug Administration (FDA) has approved cabozantinib tablets for the treatment of patients with hepatocellular carcinoma (HCC) who have previously received sorafenib treatment. HCC is the most common form of liver cancer and one of the fastest-growing causes of cancer-related deaths in the United States.
“This new indication for cabozantinib represents a significant advance in the treatment of this aggressive liver cancer, a patient population in dire need of new treatment options,” said Dr. Michael M. Morrissey, President and CEO of Ipsen Pharmaceuticals. “This approval is an important milestone, and we will continue to explore the potential benefits of cabozantinib in other refractory cancers beyond renal cell carcinoma. We thank the patients and clinicians who participated in the CELESTIAL study and the FDA team for their continued collaboration throughout the review of our application.”
The FDA approval of cabozantinib is based on the results of the pivotal Phase 3 CELESTIAL trial in patients with advanced HCC who had previously received sorafenib. Compared to placebo, cabozantinib demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS). On November 15, 2018, Ipsen Pharmaceuticals' partner, Ipsen, received approval from the European Commission for cabozantinib tablets as monotherapy for adult HCC patients who have previously received sorafenib treatment.
“Patients with this type of advanced liver cancer have limited treatment options, especially when their disease progresses after sorafenib treatment,” said Dr. Ghassan K. Abou-Alfa, MD, principal investigator of the CELESTIAL trial at Memorial Sloan Kettering Cancer Center, New York. “Physicians are eager to provide new options for these patients, and the results of the CELESTIAL trial demonstrate the efficacy and safety of cabozantinib, making it an important new therapy in our efforts to slow disease progression and improve treatment outcomes.”
About Cabozantinib
Cabozantinib tablets are approved in the United States for the treatment of patients with advanced renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC) who have previously received sorafenib treatment.
Cabozantinib tablets are also approved in the following regions: the EU, Norway, Iceland, Australia, Switzerland, South Korea, Hong Kong, Ukraine, Canada, Taiwan, Jordan, and Macau, for the treatment of advanced RCC in adults who have previously received VEGF-targeted therapy; in the EU, Norway, Iceland, Australia, and Jordan, for the treatment of previously untreated intermediate- or high-risk advanced RCC; in Canada, for the treatment of advanced RCC in adults who have previously received VEGF-targeted therapy; in Brazil, for the treatment of advanced or metastatic RCC; and in the EU, Norway, and Iceland, for the treatment of HCC in adults who have previously received sorafenib.
In 2016, Ipsen granted Ipsen exclusive rights to commercialize cabozantinib and conduct further clinical development outside the United States and Japan.
In 2017, Ipsen granted Takeda Pharmaceutical Company Limited exclusive rights to commercialize cabozantinib and conduct further clinical development for all future indications in Japan.
