FDA grants priority review to Opdivo with Cabometyx for renal cell carcinoma
Click Here to Manage Email Alerts
The FDA granted priority review to nivolumab in combination with cabozantinib for treatment of advanced renal cell carcinoma.
The agency is expected to make a decision on approval by Feb. 20.
Nivolumab (Opdivo, Bristol Myers Squibb) is an anti-PD-1 antibody. Cabozantinib (Cabometyx, Exelixis) is a multitargeted tyrosine kinase inhibitor.
The FDA based the priority review designation on results of the randomized phase 3 CheckMate -9ER trial, presented at ESMO Virtual Congress 2020.
The trial included 651 patients with previously untreated advanced or metastatic renal cell carcinoma with a clear cell component.
Researchers randomly assigned 323 patients to nivolumab dosed at 240 mg every 2 weeks in combination with cabozantinib dosed at 40 mg daily. The other 328 patients received standard sunitinib (Sutent, Pfizer) dosed at 50 mg daily in a 4-weeks-on, 2-weeks-off schedule. Treatment continued until disease progression or unacceptable toxicity.
As Healio previously reported, results showed patients assigned nivolumab-cabozantinib achieved significantly longer PFS — the study’s primary endpoint — as well as superior OS and objective response rates, both of which served as secondary endpoints.
The combination also exhibited a manageable safety profile. Patient-reported outcomes data showed statistically significant improvements in health-related quality of life at most time points with the combination vs. sunitinib.
“We have witnessed practice-changing advancements in the treatment of renal cell carcinoma in recent years, but we recognize the importance of providing patients and physicians with additional options that can help them take control of the disease,” Mark Rutstein, vice president and development program lead of nivolumab for Bristol Myers Squibb, said in a company-issued press release. “In the CheckMate -9ER trial, combining Opdivo and Cabometyx — two proven agents with strong clinical legacies in advanced renal cell carcinoma — led to superior efficacy across all endpoints. We look forward to working with the FDA to bring this potential treatment option to physicians and their patients who choose an immunotherapy-plus-tyrosine kinase inhibitor regimen.”
Click Here to Manage Email Alerts