FDA Approves Exelixis’ Cabometyx To Treat Metastatic Differentiated Thyroid Cancer

The U.S. Food and Drug Administration approved Exelixis Inc.’s (EXEL) Cabometyx or cabozantinib for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior vascular endothelial growth factor receptor or VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible.

The FDA granted Breakthrough Therapy designation and Priority Review to Cabometyx and its approval comes more than two months ahead of the Prescription Drug User Fee Act (PDUFA) target action date of December 4, 2021.

The FDA approval was based on phase 3 COSMIC-311 pivotal trial, which demonstrated significant improvement in progression-free survival with Cabometyx versus placebo.

In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC; for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib; for patients with advanced RCC as a first-line treatment in combination with nivolumab; and for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible.

CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide.

In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan.

In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.

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