Policy & Regulation
US FDA Accepts for Priority Review Applications for Opdivo, Cabometyx Combination in Advanced Renal Cell Carcinoma
20 October 2020 - - The US Food and Drug Administration has accepted the supplemental Biologics License Application and supplemental New Drug Application, respectively, for Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) for patients with advanced renal cell carcinoma, US-based pharmaceutical company Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (NASDAQ: EXEL) said.

The FDA granted Priority Review to both applications and assigned a Prescription Drug User Fee Act (PDUFA) goal date, or target action date, of February 20, 2021.

These filings were based on results from the Phase 3 CheckMate -9ER trial, which evaluated OPDIVO in combination with Cabometyx in patients with previously untreated advanced RCC versus sunitinib.

In CheckMate -9ER, Opdivo in combination with Cabometyx demonstrated significant improvements across all efficacy endpoints, including overall survival, progression-free survival and objective response rate, versus the comparator, sunitinib.

The combination of Opdivo plus Cabometyx was well tolerated, with a low rate of treatment-related discontinuations, and reflected the known safety profiles of the immunotherapy and tyrosine kinase inhibitor components in patients with previously untreated advanced RCC.

In addition, patient-reported outcomes data from CheckMate -9ER showed that Opdivo in combination with CABOMETYX was associated with statistically significant improvements in health-related quality of life at most time points versus sunitinib.

On September 19, 2020, results from the trial were presented as a Proffered Paper during a presidential Symposium at the European Society for Medical Oncology Virtual Congress 2020.

Bristol Myers Squibb and Exelixis thank the patients and investigators who were involved in the CheckMate -9ER clinical trial.

CheckMate -9ER is an open-label, randomized, multi-national Phase 3 trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma.

A total of 651 patients (23% favorable risk, 58% intermediate risk, 20% poor risk; 25% PD-L1≥1%) were randomized to receive Opdivo plus Cabometyx (n=323) vs. sunitinib (n=328). The primary endpoint is progression-free survival.

Secondary endpoints include overall survival and objective response rate. The primary efficacy analysis is comparing the doublet combination vs. sunitinib in all randomized patients.

The trial is sponsored by Bristol Myers Squibb and Ono Pharmaceutical Co and co-funded by Exelixis, Ipsen and Takeda Pharmaceutical company Ltd.

Renal cell carcinoma is the most common type of kidney cancer in adults, accounting for more than 140,000 deaths worldwide each year.

RCC is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe. The five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 12.1%.
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