Cabometyx Approved for Thyroid Cancer

FDA has approved an Exelixis NDA for Cabometyx (cabozantinib) for treating 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 ineligible or refractory to radioactive iodine. Approval was based on data from the COSMIC-311 clinical trial, where patients were randomized to receive either cabozantinib 60 mg orally once daily or placebo with best supportive care until disease progression or intolerable toxicity, according to an FDA news release.

In the trial, Cabometyx significantly reduced the risk of disease progression or death versus placebo, the agency says. The median progression-free survival was 11.0 months in the cabozantinib arm compared to 1.9 months in those receiving placebo. The objective response rate was 18% and 0% in the cabozantinib and placebo arms, respectively, it says.