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

Excerpt from the Press Release:

ALAMEDA, Calif.–(BUSINESS WIRE)–Mar. 31, 2021– Exelixis, 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.

“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.”

The 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.

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