Exelixis: Health Canada approves Cabometyx in advanced renal cell carcinoma

Exelixis’ (EXEL) partner Ipsen Biopharmaceuticals Canada Inc. received approval of Cabometyx®(cabozantinib) tablets from Health Canada for adults with advanced renal cell carcinoma (RCC) who have received prior vascular endothelial growth factor (VEGF) targeted therapy. Health Canada had granted Cabometyx priority review status, which resulted in the accelerated review of Ipsen’s new drug submission.

Explaining the importance of Cabometyx’s additional approval, Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis said that the approval 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.

The Health Canada approval was based on results of the phase 3 pivotal METEOR trial in which Cabometyx has provided a statistically significant and clinically meaningful improvement in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) as compared with everolimus in patients with advanced RCC who have received prior anti-angiogenic therapy.

Advanced Renal Cell Carcinoma

The American Cancer Society’s 2018 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S. Approximately 6,600 new cases were diagnosed in 2017. Clear cell RCC is the most common type of kidney cancer in adults. For patients with advanced or late-stage metastatic RCC the five-year survival rate is only 12 percent, with no identified cure for the disease. Approximately 30,000 patients in the U.S. and 68,000 globally require treatment, and an estimated 14,000 patients in the U.S. each year are in need of a first-line treatment for advanced kidney cancer.

Exelixis/Ipsen Agreement

In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. Under the terms of the Collaboration Agreement with Ipsen, Exelixis is entitled to receive a tiered royalty of 22 percent to 26 percent of annual net sales.

Prohost Observations

Cabometyx tablets are approved in many countries, including the United States, Europe, Norway, Iceland, Australia, Switzerland and South Korea for the treatment RCC. The FDA has granted orphan drug designation to cabozantinib for the treatment of advanced hepatocellular carcinoma (HCC). On March 28, 2018, 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 for the commercialization and further clinical development of cabozantinib for all future indications in Japan.

 Why do we appreciate cabometix

Cabometyx (Cabozantinib) is a receptor tyrosine kinase inhibitor with activity against MET, VEGFR2, FLT3, c-KIT, and RET. The product effect toward a broad range of tumor models could be understood from the product’s mode of action and its results on cancers, which was detected in several preclinical studies.

Preclinical studies demonstrated that the product decreases metastasis potential and tumor invasiveness when compared with placebo or agents that target VEGFR and have no activity against MET. The results explain why Cabometix succeeded in advanced RCC. The majority of clear cell RCC tumors have lower than normal levels of a protein called von Hippel-Lindau, which leads to higher levels of MET, AXL and VEGF. These proteins promote blood vessel growth, invasiveness and metastasis. MET and AXL may provide escape pathways that drive resistance to VEGF receptor inhibitors.

Based on the above, can we fairly expect Cabometyx(Cabozantib) to pass many other clinical tests for the treatment of several other advanced cancers with unmet needs?

We do.


Portola (PTLA) has news that we will be post soon under Today’s Highlights.  

We will further elaborate on this news and other aspects of the firm’s programs in the next issue of The Week in Review.



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