Research & Development
US FDA Approval of Cabometyx in Combination with Opdivo as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma
25 January 2021 - - The US Food and Drug Administration approved Cabometyx (cabozantinib) for patients with advanced renal cell carcinoma as a first-line treatment in combination with Opdivo (nivolumab), US-based Exelixis, Inc. (NASDAQ: EXEL) said.

RCC is the most common form of kidney cancer, which is among the 10 most frequently diagnosed cancers in the U.S. annually.

The approval is based on results from CheckMate -9ER, a phase 3 pivotal trial evaluating the combination of Cabometyx and Opdivo compared with sunitinib in previously untreated advanced or metastatic RCC. These results were presented during the European Society of Medical Oncology Virtual Congress 2020 in September.

The FDA reviewed the application for Cabometyx and Opdivo under the Real-Time Oncology Review pilot program and Fast Track designation.

The RTOR pilot program, which allows an applicant to pre-submit components of the application to allow the FDA to review clinical trial data before the complete filing is submitted, aims to explore a more efficient review process to ensure safe and effective treatments are available to patients sooner.

In CheckMate -9ER, the combination regimen significantly improved overall survival compared with sunitinib (HR= 0.60, 98.89% CI 0.40-0.89; p=0.001).

Median OS has not yet been reached in either treatment arm. Median progression-free survival was doubled at 16.6 months for Cabometyx in combination with Opdivo compared with 8.3 months for sunitinib (HR 0.51, 95% CI 0.41-0.64; p


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