- CABOMETYX is the only preferred tyrosine kinase inhibitor (TKI) treatment option for first-line patients in the poor- and intermediate-risk groups (Category 2A)
- CABOMETYX is a recommended first-line treatment option for favorable-risk patients (Category 2B)
- CABOMETYX is the only preferred TKI treatment option for previously treated patients (Category 1)
- Exelixis submitted a sNDA for Cabometyx in previously treated advanced HCC in May of 2018
Exelixis, Inc. (NASDAQ:EXEL) announced on 9/7/18 that the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines to include new recommendations for Cabometyx (cabozantinib) tablets. With the updates, Cabometyx is recommended by the NCCN for the treatment of advanced renal cell carcinoma (RCC) regardless of patient risk status (favorable-, intermediate-, and poor-risk).
“ Cabometyx is the only TKI indicated for the treatment of advanced kidney cancer with NCCN-preferred status for intermediate- and poor-risk groups in the first-line setting and the only TKI with preferred status for patients who have progressed on prior therapy,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “We welcome these updated recommendations, which recognize the significance of the CABOSUN trial data included in our label as an important advance in the care of patients with this disease.”
The NCCN Clinical Practice Guidelines are the recognized standard for clinical policy in cancer care and are developed through review of evidence and recommendations from physicians and oncology researchers. The NCCN kidney cancer panel’s decision to include Cabometyx as a Category 2A preferred option for the treatment of patients with previously untreated advanced RCC with poor- or intermediate-risk disease was based on the results of the phase 2 CABOSUN trial.
Additionally, in its recent update to the Clinical Practice Guidelines for Hepatobiliary Cancers, the NCCN added cabozantinib as a Category 1 option for the treatment of patients with hepatocellular carcinoma (HCC) (Child-Pugh Class A only) who have been previously treated with sorafenib. Cabometyx is not FDA-approved for previously treated advanced HCC. On May 29, 2018, the U.S. FDA accepted the supplemental New Drug Application for Cabometyx in previously treated advanced HCC and assigned it a Prescription Drug User Fee Act (PDUFA) action date of January 14, 2019.
In late August of 2018 it was announced that the National Institute for Health and Care Excellence in the UK had begun recommending Cabometyx for adults with advanced renal cell carcinoma.
Cabometyx is a tyrosine kinase inhibitor, which inhibits activity of the RET, MET, VEGFR2 (vascular endothelial growth factor 2) and other receptor tyrosine kinases.
These receptor tyrosine kinases are responsible for normal cellular function and pathogenesis such as oncogenesis, tumour angiogenesis.
By inhibiting the activity of these receptor kinases, it blocks oncogenesis, metastasis and supply of blood vessels and nutrients to the tumours.
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. Clear cell RCC is the most common type of kidney cancer in adults.6 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, 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.
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 tumor angiogenesis (blood vessel growth), growth, invasiveness and metastasis. MET and AXL may provide escape pathways that drive resistance to VEGF receptor inhibitors.