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Exelixis’ Partner Ipsen Receives Positive CHMP Opinion for CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma
– CHMP recommendation follows U.S. FDA approval of CABOMETYX in combination with OPDIVO in January – ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc.
About this update from Exelixis, Inc.
[{"type":"text","content":"\n– CHMP recommendation follows U.S. FDA approval of CABOMETYX in combination with OPDIVO in January –\n\n ALAMEDA, Calif.--(BUSINESS WIRE)--\nExelixis, Inc. (NASDAQ: EXEL) today announced that its partner Ipsen received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), for CABOMETYX® (cabozantinib) in combination with OPDIVO® (nivolumab) for the first-line treatment of advanced renal cell carcinoma (RCC). The European Commission, which has the authority to approve medicines for the European Union, will now review the CHMP recommendation, and a final decision on the application is expected in the coming months.\n\n“On the heels of the FDA approval of CABOMETYX in combination with OPDIVO in the U.S., we are excited that this CHMP recommendation brings our partner Ipsen one step closer to making this combination regimen available as a first-line treatment option for patients with advanced kidney cancer in Europe,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “We look forward to hearing the European Commission’s decision in the coming months and to continuing our collaboration with Ipsen as part of our efforts to bring CABOMETYX to more patients with difficult-to-treat cancers.”\n\nCABOMETYX is currently 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 CHMP recommendation to approve CABOMETYX in combination with OPDIVO for the first-line treatment of advanced RCC follows the submission of type II variations to the marketing authorizations to the EMA by Ipsen and Bristol Myers Squibb, respectively, and validation of the submissions in September 2020. The submissions are based on results from the phase 3 CheckMate -9ER 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 trial was the basis for the U.S. Food and Drug Administration (FDA) approval of CABOMETYX in combination with...