27

January

Exelixis announces FDA approval for CABOMETYX(R) (cabozantinib) with OPDIVO(R) (nivolumab)

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.

 

Victoria

Victoria has blogged 1340 posts