Exelixis, Inc. (Nasdaq: EXEL) today announced Takeda Pharmaceutical Company Limited (Takeda), its partner responsible for the clinical development and commercialization of CABOMETYX® (cabozantinib) in Japan, and Ono Pharmaceutical Co., Ltd. (Ono) received approval from the Japanese Ministry of Health, Labor and Welfare to manufacture and market CABOMETYX in combination with OPDIVO® (nivolumab) as a treatment for unresectable or metastatic renal cell carcinoma (RCC).

Opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma.

CABOMETYX is a kinase inhibitor indicated for the treatment of...patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab.

Systemic Therapy for Non-Clear Cell Histology...Other Recommended Regimens...Nivolumab + cabozantinib was added as a category 2A recommendation.

...updated treatment recommendations for first-line advanced clear cell renal cancer….combination of cabozantinib and nivolumab, which is now recommended as front-line therapy for advanced disease…

With extended follow-up and preplanned final overall survival analysis per protocol, nivolumab plus cabozantinib demonstrated improved efficacy versus sunitinib, further supporting the combination in the first-line treatment of advanced renal cell carcinoma.

...the phase 3 CheckMate -9ER trial with CABOMETYX® (cabozantinib) in combination with Bristol Myers Squibb’s OPDIVO® (nivolumab) compared with sunitinib as a first-line treatment for advanced renal cell carcinoma (RCC)….median progression-free survival (PFS) was doubled at 17.0 months for CABOMETYX in combination with OPDIVO compared with 8.3 months for sunitinib (hazard ratio [HR]: 0.52; 95% confidence interval [CI]: 0.43-0.64; P<0.0001)...Objective response rate (ORR) was 54.8% with CABOMETYX in combination with OPDIVO versus 28.4% with sunitinib, and complete response (CR) rate was 9.3% versus 4.3%, respectively.

Nivolumab plus cabozantinib had significant benefits over sunitinib with respect to progression-free survival, overall survival, and likelihood of response in patients with previously untreated advanced renal-cell carcinoma...The probability of overall survival at 12 months was 85.7% (95% CI, 81.3 to 89.1) with nivolumab plus cabozantinib and 75.6% (95% CI, 70.5 to 80.0) with sunitinib (hazard ratio for death, 0.60; 98.89% CI, 0.40 to 0.89; P=0.001). An objective response occurred in 55.7% of the patients receiving nivolumab plus cabozantinib and in 27.1% of those receiving sunitinib (P<0.001).

Bristol Myers Squibb...announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) for the first-line treatment of adults with advanced renal cell carcinoma (RCC)...The CHMP adopted the positive opinion based on results from the Phase 3 CheckMate -9ER trial, which demonstrated significant and clinically meaningful improvements in progression-free survival (PFS), overall survival (OS) and objective response rate (ORR)...

At a median follow-up of 18.1 months, NIVO+CABO improved PFS, OS, and ORR in sRCC pts vs SUN...Notable PFS, OS, and ORR benefits were observed with NIVO+CABO vs SUN in the subgroup of pts without sRCC....NIVO+CABO demonstrated improved efficacy and prolonged survival vs SUN in previously untreated aRCC pts regardless of sarcomatoid status.

Bristol Myers Squibb...and Exelixis, Inc....today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) and supplemental New Drug Application (sNDA), respectively, for OPDIVO® (nivolumab) in combination with CABOMETYX® (cabozantinib) for patients with advanced renal cell carcinoma (RCC). The FDA granted Priority Review to both applications...