Exelixis is pleased to announce the FDA approval of its first combination therapy–CABOMETYX + OPDIVO–for the first-line treatment of patients with advanced renal cell carcinoma (aRCC).1
This new approval in aRCC is supported by clinical data from the CheckMate-9ER trial. The major efficacy outcome measure was PFS.* Additional efficacy outcome measures were OS and ORR.* Based on the results of CheckMate-9ER, CABOMETYX + OPDIVO is the first and only 1L aRCC combination treatment to double PFS and ORR while delivering superior OS.1 Please see the data of CABOMETYX + OPDIVO vs sunitinib below.
*PFS and ORR were assessed by BICR.1
1L=first-line; BICR=blinded independent central review; ORR=objective response rate;
OS=overall survival; PFS=progression-free survival.
INDICATIONS
CABOMETYX® (cabozantinib), in combination with nivolumab, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (aRCC).
CABOMETYX is indicated for the treatment of patients with aRCC.
SELECT IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hemorrhage: Severe and fatal hemorrhages occurred with CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies. Discontinue CABOMETYX for Grade 3 or 4 hemorrhage. Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.
Please see additional Important Safety Information for CABOMETYX below and full Prescribing Information by clicking here.
