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Thursday, August 5, 2021

Exelixis gets priority review for Cabometyx for thyroid cancer

 U.S. Food and Drug Administration assigned a Prescription Drug User Fee Act action date of December 4, 2021 –

– The supplemental New Drug Application is based on the phase 3 COSMIC-311 pivotal trial, which demonstrated significant improvement in progression-free survival with CABOMETYX versus placebo 

https://www.businesswire.com/news/home/20210805005256/en/Exelixis-Announces-U.S.-FDA-Accepts-for-Priority-Review-the-Supplemental-New-Drug-Application-for-CABOMETYX%C2%AE-cabozantinib-for-Patients-with-Previously-Treated-Radioactive-Iodine-Refractory-Differentiated-Thyroid-Cancer

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