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Exelixis’ Partner Ipsen Receives European Commission Approval for CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma
– Approval based on CheckMate -9ER trial, in which CABOMETYX in combination with OPDIVO doubled progression-free survival and objective response rate while
About this update from Exelixis, Inc.
[{"type":"text","content":"\n– Approval based on CheckMate -9ER trial, in which CABOMETYX in combination with OPDIVO doubled progression-free survival and objective response rate while significantly improving overall survival versus sunitinib –\n\n ALAMEDA, Calif.--(BUSINESS WIRE)--\nExelixis, Inc. (Nasdaq: EXEL) today announced its partner Ipsen received approval from the European Commission (EC) for CABOMETYX® (cabozantinib) in combination with OPDIVO® (nivolumab) as a first-line treatment for advanced renal cell carcinoma (RCC). This approval allows for the marketing of CABOMETYX in combination with OPDIVO in this indication in all 27 member states of the European Union, Norway, Iceland and Liechtenstein.\n\n“We are excited that CABOMETYX in combination with OPDIVO will now be available in Europe, where newly diagnosed kidney cancer patients are in need of additional options that have shown consistent superiority compared to sunitinib across all key efficacy endpoints of progression-free survival, objective response rate and overall survival with a low rate of treatment discontinuations due to side effects,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “We look forward to continuing our collaboration with Ipsen with the shared goal of improving treatment outcomes for people with cancer.”\n\nThe EC approval is based on results of the phase 3 CheckMate -9ER pivotal trial, in which the combination regimen doubled progression-free survival (PFS) and objective response rate (ORR) while significantly improving overall survival (OS) compared with sunitinib. The combination regimen was generally well tolerated and reflected the known safety profiles of the tyrosine kinase inhibitor and immunotherapy components in previously untreated advanced RCC.\n\nCABOMETYX is also approved in the European Union as a monotherapy for the treatment of advanced RCC in adults who have received prior VEGF-targeted therapy, for previously untreated intermediate- or poor-risk advanced RCC, and for hepatocellular carcinoma (HCC) in adults who have been previously treated with sorafenib. The EC approval of CABOMETYX in combination with OPDIVO follows the U.S. Food and Drug Administration’s (FDA) approval of the combination regimen for the first-line treatment of advanced RCC in January 2021.\n\nAbout the CheckMate ...