NCCN updates Clinical Practice Guidelines to include new recommendations for CABOMETYX tablets

Exelixis, Inc. today announced 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).

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

• 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)

"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.