Cabozantinib Granted Fast-Track Designation for Renal Cell Carcinoma
FDA has granted fast-track designation to cabozantinib (Cometriq) for treatment of RCC who have received prior therapy.
The FDA has granted fast-track designation to cabozantinib (Cometriq) for treatment of patients with advanced renal cell carcinoma (RCC) who have received prior therapy, according to a release.
Developed by Exelixis, cabozantinib is currently being studied in METEOR, an ongoing phase III trial that looks at patients with metastatic RCC who experience disease progression upon treatment with at least one VEGFR tyrosine kinase inhibitor.
Subjects are randomized to either cabozantinib (60 mg) or everolimus (10 mg) daily, with primary endpoint as progression-free survival and secondary endpoint as overall survival and response rate.
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Exelixis is also studying the effects of cabozantinib in CELESTIAL, another phase III trial for the treatment of second-line hepatocellular carcinoma.
Cabozantinib is currently approved by the FDA for treatment of progressive, metastatic medullary thyroid cancer.