FDA approves Exelixis’ cancer drug Cabometyx
The FDA has approved Exelixis’ Cabometyx (cabozantinib) for patients with advanced renal cell carcinoma (RCC) as a first-line treatment in combination with Opdivo (nivolumab).
RCC is the most common form of kidney cancer, which is among the 10 most frequently diagnosed cancers in the US annually.
The approval is based on results from CheckMate -9ER, a Phase III pivotal trial evaluating the combination of Cabometyx and Opdivo compared with sunitinib in previously untreated advanced or metastatic RCC. The trial showed that the combination regimen significantly improved overall survival 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 was also doubled: 56% with Cabometyx in combination with Opdivo and 27% with sunitinib. Consistent results for PFS were observed across subgroups of International Metastatic RCC Database Consortium risk status and PD-L1 tumour expression with Cabometyx in combination with Opdivo.
The FDA reviewed the application for the two drugs under the Real-Time Oncology Review (RTOR) 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.
Michael M. Morrissey, President and Chief Executive Officer of Exelixis, said: “As the only combination treatment regimen to double median progression-free survival and objective response rate compared with sunitinib while also significantly improving overall survival, we are excited that Cabometyx in combination with Opdivo is now available for the first-line treatment of patients with advanced kidney cancer.
“This approval is a meaningful milestone for this patient community and speaks to the broad potential of Cabometyx as we continue to generate important clinical trial results supporting its use in combination with immune checkpoint inhibitors to benefit patients with other difficult-to-treat cancers. We would like to thank the clinical trial participants, the physicians, and their staff who participated in the CheckMate -9ER trial, and to acknowledge the team at the FDA for their collaboration during the review of our application.”
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