New Recommendations for Cabozantinib Tablets in Updated NCCN Clinical Practice Guidelines

Recently, the National Comprehensive Cancer Network® (NCCN®) updated its Clinical Practice Guidelines to include new recommendations for cabozantinib (Cabometyx) tablets. With the updates, cabozantinib is recommended by the NCCN for the treatment of advanced renal cell carcinoma regardless of patient risk status (favorable-, intermediate-, and poor-risk).

Key cabozantinib-related highlights from the updated NCCN Clinical Practice Guidelines for Kidney Cancer include:

  • Cabozantinib is the only preferred tyrosine kinase inhibitor 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 tyrosine kinase inhibitor treatment option for previously treated patients (category 1).

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 decision by the NCCN Kidney Cancer Panel to include cabozantinib as a category 2A preferred option for the treatment of patients with previously untreated advanced renal cell carcinoma with poor- or intermediate-risk disease was based on the results of the phase II 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 (Child-Pugh Class A only) who have been previously treated with sorafenib. Cabozantinib is not approved by the U.S. Food and Drug Administration (FDA) for previously treated advanced hepatocellular carcinoma. On May 29, 2018, the U.S. FDA accepted the supplemental new drug application for cabozantinib in previously treated advanced hepatocellular carcinoma and assigned it a Prescription Drug User Fee Act action date of January 14, 2019.

About the CABOSUN Study

The CABOSUN study met its primary endpoint in May 2016, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival compared with sunitinib in patients with advanced intermediate- or poor-risk renal cell carcinoma as determined by investigator assessment. These results were first presented by Toni Choueiri, MD, at the European Society for Medical Oncology (ESMO) 2016 Congress and were published in the Journal of Clinical Oncology. In June 2017, a blinded independent review committee confirmed that cabozantinib provided a clinically meaningful and statistically significant improvement in the primary efficacy endpoint of investigator-assessed progression-free survival. Results from the independent review committee review were presented by Dr. Choueiri at the ESMO 2017 Congress.

CABOSUN was a randomized, open-label, active-controlled phase II trial that enrolled 157 patients with advanced renal cell carcinoma determined to be intermediate- or poor-risk by the International Metastatic Renal Cell Carcinoma Database (IMDC) criteria. Patients were randomized 1:1 to receive cabozantinib (60 mg once daily) or sunitinib (50 mg once daily, 4 weeks on followed by 2 weeks off). Eligible patients were required to have locally advanced or metastatic clear cell renal cell carcinoma, an Eastern Cooperative Oncology Group performance status of between 0 and 2, and had to be intermediate- or poor-risk per the IMDC criteria. Prior systemic treatment for renal cell carcinoma was not permitted.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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