NCCN Recommends Cabozantinib for Advanced RCC Treatment Across All Patient Risk Groups

The National Comprehensive Cancer Network updated its Clinical Practice Guidelines for kidney cancer to include new recommendations for cabozantinib tablets.

Treatment with cabozantinib (Cabometyx) tablets is now recommended by the National Comprehensive Cancer Network (NCCN) for patients with advanced renal cell carcinoma (RCC) regardless of risk status, Exelixis announced in a press release.

Kidney cancer is among the top 10 most commonly diagnosed forms of cancer in the United States, according to the American Cancer Society. The 5-year survival rate for RCC is high if detected early on, but 5-year survival for patients with advanced or late-stage disease is only 12%.

The new recommendations are included in the NCCN’s updated Clinical Practice Guidelines for Kidney Cancer. Other updates include:

  • Cabozantinib is the only preferred tyrosine kinase inhibitor (TKI) treatment option for first-line patients in the poor- and intermediate-risk groups (Category 2A).
  • Cabozantinib is a recommended first-line treatment option for favorable-risk patients (Category 2B).
  • Cabozantinib is the only preferred TKI treatment option for previously treated patients (Category 1).

The NCCN kidney cancer panel’s decision to include cabozantinib 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, according to the press release.

The CABOSUN trial included 157 patients with advanced RCC determined to be intermediate- or poor-risk by the IMDC criteria. Patients received either cabozantinib (60 mg once daily) or sunitinib (50 mg once daily, 4 weeks on followed by 2 weeks off). Cabozantinib-treated patients demonstrated a statistically significant and clinically meaningful improvement in PFS compared with sunitinib-treated patients, according to the results.

In its recently updated Clinical Practice Guidelines for Hepatobiliary Cancers, the NCCN also added cabozantinib as a Category 1 option for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib.

The NCCN Clinical Practice Guidelines, developed through expert review of evidence and recommendations from physicians and oncology researchers, are the recognized standard for clinical policy in cancer care.


Exelixis Announces New Recommendations for Cabometyx (Cabozantinib) Tablets in Updated National Comprehensive Cancer Network Clinical Practice Guidelines [news release]. Exelixis’ website. Accessed September 7, 2018.

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