FDA grants priority review to Cabometyx for differentiated thyroid cancer
The FDA granted priority review to cabozantinib for treatment of certain patients with differentiated thyroid cancer.
The designation applies to use of the agent by patients aged 12 years or older who progressed after prior therapy and are refractory to radioactive iodine.
Cabozantinib (Cabometyx, Exelixis) is a multitargeted tyrosine kinase inhibitor.
The FDA based the priority review on results of the randomized phase 3 COSMIC-311 trial, designed to enroll approximately 300 patients at 150 sites around the world. Patients had radioactive iodine-refractory differentiated thyroid cancer and progressed after up to two prior vascular EGFR-targeted therapies.
Researchers randomly assigned patients 2:1 to receive 60 mg cabozantinib or placebo once daily. PFS and objective response rate served as primary endpoints.
Results of a planned interim analysis showed a statistically significant PFS improvement among cabozantinib-treated patients, according to an Exelixis-issued press release.
The FDA in February granted breakthrough therapy designation to cabozantinib based on these results. The agency is expected to make a decision on approval by Dec. 4.
“The FDA’s acceptance of our [supplemental new drug application] with priority review is an important step toward our goal of bringing Cabometyx to patients with previously treated radioactive iodine-refractory differentiated thyroid cancer,” Michael M. Morrissey, PhD, president and CEO of Exelixis, said in the release. “Considering the lack of a standard of care in the treatment of this cancer following [anti-vascular EGFR] therapy, the progression-free survival benefit demonstrated in the phase 3 COSMIC-311 pivotal trial means Cabometyx, if approved, could become an important new treatment for these patients.”
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