Exelixis : Announces U.S. FDA Approval of CABOMETYX in Combination with OPDIVO as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma
January 25, 2021 at 10:43 am
Share
ALAMEDA - Exelixis, Inc. (NASDAQ: EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX for patients with advanced renal cell carcinoma (RCC) as a first-line treatment in combination with OPDIVO.
RCC is the most common form of kidney cancer, which is among the 10 most frequently diagnosed cancers in the U.S. annually.1
'This combination of cabozantinib and nivolumab significantly improved key efficacy measures compared to sunitinib - progression-free survival, overall survival and objective response rate - while showing a low rate of treatment discontinuations due to side effects. The therapeutic benefit demonstrated in CheckMate -9ER and quality of life measures explored emphasize the role of this combination for patients with advanced kidney cancer,' said Dr. Toni Choueiri, 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. 'With this important FDA approval, the combination is poised to become a standard in newly diagnosed metastatic kidney cancer.'
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 (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.
'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,' said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. '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.'
In CheckMate -9ER, the combination regimen significantly improved overall survival (OS) 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 (PFS) 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
Exelixis, Inc. is an oncology company. The Company is engaged in developing medicines and combination regimens at the forefront of cancer care. It has produced four marketed pharmaceutical products, two of which are formulations of its flagship molecule, cabozantinib. Cabozantinib is an inhibitor of multiple tyrosine kinases, including MET, AXL, VEGF receptors and RET and has been also approved as CABOMETYX tablets for advanced renal cell carcinoma (RCC), for previously treated hepatocellular carcinoma (HCC) and for previously treated, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC), and as COMETRIQ capsules for progressive, metastatic medullary thyroid cancer (MTC). The Company's other two products are COTELLIC, an inhibitor of MEK approved as part of multiple combination regimens to treat specific forms of advanced melanoma and MINNEBRO an oral, non-steroidal, selective blocker of the mineralocorticoid receptor (MR) approved the treatment of hypertension.
Exelixis : Announces U.S. FDA Approval of CABOMETYX in Combination with OPDIVO as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma
EXELIXIS, INC. 
