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FDA cleared cabozantinib (Cabometyx) for patients with advanced renal cell carcinoma as a first-line treatment in combination with nivolumab (Opdivo).
FDA cleared cabozantinib (Cabometyx, Exelixis) for patients with advanced renal cell carcinoma (RCC) as a first-line treatment in combination with nivolumab (Opdivo, Bristol Myers Squibb).
Cabometyx tablets are already approved for treatment of advanced RCC and hepatocellular carcinoma when patients have been previously treated with sorafenib.
Opdivo and Opdivo-based combinations are approved to treat multiple forms of cancer, including nonsmall cell lung cancer and malignant pleural mesothelioma.
"This combination of cabozantinib and nivolumab significantly improved key efficacy measures compared to sunitinib [Sutent, Pfizer] – progression-free survival, overall survival and objective response rate – while showing a low rate of treatment discontinuations due to side effects," said Toni Choueiri, M.D. director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and the Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School, in a press release.
The approval is based on results from a phase 3 pivotal trial, which found that the combination regimen significantly improved overall survival (OS) compared with sunitinib. Median progression-free survival (PFS) was doubled at 16.6 months for Cabometyx in combination with Opdivo, compared with 8.3 months for sunitinib.
Objective response rate (ORR) was also doubled: 56% with Cabometyx in combination with Opdivo versus 27% with sunitinib.
"While significant progress has been made in the treatment landscape for advanced kidney cancer over the last several years, patients still need more therapeutic options to treat this disease as we search for a possible cure," said Bryan Lewis, president and co-founder of KidneyCAN. “The findings for the combination of Cabometyx and Opdivo in the CheckMate -9ER trial make the FDA approval of this combination a notable development for the patient community."