Canada Approves Cabometyx for Adults with Previously Treated Advanced Renal Cell Carcinoma

  • Cabometyx has orphan drug status in the US
  • Takeda has rights to all indications for Cabometyx in Japan

Exelixis, Inc.  (NASDAQ:EXEL) announced on 9/19/18 that its partner Ipsen Biopharmaceuticals Canada Inc. received approval from Health Canada of Cabometyx   (cabozantinib) tablets for the treatment of adults with advanced renal cell carcinoma (RCC) who have received prior vascular endothelial growth factor (VEGF) targeted therapy. Health Canada granted Cabometyx priority review status, which provided an accelerated review of Ipsen’s new drug submission.

“The approval of Cabometyx in Canada helps address a significant unmet need for patients with advanced kidney cancer whose disease has progressed on first-line therapy and who have limited treatments available,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “We are glad to be partnering with Ipsen to bring this much needed treatment option to these patients and look forward to our continued collaboration.”

Cabometyx tablets are approved in the United States for the treatment of patients with advanced RCC. Cabometyx tablets are also approved in: the European Union, Norway, Iceland, Australia, Switzerland and South Korea for the treatment of advanced RCC in adults who have received prior VEGF-targeted therapy; in the European Union for previously untreated intermediate- or poor-risk advanced RCC; and in Canada for adult patients with advanced RCC who have received prior VEGF targeted therapy. In March 2017, the FDA granted orphan drug designation to cabozantinib for the treatment of advanced HCC. On March 28, 2018, Ipsen announced that the European Medicines Agency validated its application for a new indication for cabozantinib as a treatment for previously treated advanced HCC in the European Union. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan.

Cabometyx inhibits key receptors, including VEGFR, MET, and AXL, which are involved in normal and pathologic processes such as tumor growth, invasiveness, angiogenesis, and metastasis.