San Francisco, CA (UroToday.com) -- Exelixis, Inc. announced that its partner Ipsen Biopharmaceuticals Canada Inc. received approval from Health Canada of CABOMETYX® (cabozantinib) tablets for the treatment of adults with advanced renal cell carcinoma (RCC) who have received prior vascular endothelial growth factor (VEGF) targeted therapy. Health Canada granted CABOMETYX priority review status, which provided an accelerated review of Ipsen’s new drug submission.
“The approval of CABOMETYX in Canada helps address a significant unmet need for patients with advanced kidney cancer whose disease has progressed on first-line therapy and who have limited treatments available,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “We are glad to be partnering with Ipsen to bring this much needed treatment option to these patients and look forward to our continued collaboration.”The Health Canada approval was based on results of the phase 3 pivotal METEOR trial in which CABOMETYX provided a statistically significant and clinically meaningful improvement in overall survival, progression-free survival and objective response rate as compared with everolimus in patients with advanced RCC who have received prior anti-angiogenic therapy.
Under the terms of the Collaboration Agreement with Ipsen, Exelixis will receive a milestone payment of $5 million for the Health Canada approval. The payment will be made by Ipsen within the next 70 days.
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Important Safety Information and Full U.S. Prescribing Information
Outcomes based on age in the phase 3 METEOR trial of cabozantinib (cabo) vs everolimus (eve) in patients with advanced renal cell carcinoma (RCC)
Quality of Life Outcomes for Cabozantinib Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma: METEOR Phase III Randomized Trial.