(Thyroid Cancer) FDA Approves CABOMETYX for Treatment
(Thyroid Cancer) FDA Approves CABOMETYX for Treatment
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(Thyroid Cancer) FDA Approves CABOMETYX for Treatment
- September 29, 2021
- Reading time: 1 minute
On September 17, 2021, the U.S. Food and Drug Administration (FDA) approved CABOMETYX for adult and pediatric patients (12 years and older) with locally advanced or metastatic differentiated thyroid cancer that is radioiodine-refractory and has disease progression after prior VEGFR-targeted therapy.
This approval was based on the COSMIC-311 clinical trial, a multicenter randomized double-blind clinical trial that divided patients with locally advanced or metastatic differentiated thyroid cancer that is radioiodine-refractory and has disease progression after prior VEGFR-targeted therapy in a 2:1 ratio into CABOMETYX group and placebo group, continuing until disease progression or intolerable adverse effects.
The median progression-free survival (primary endpoint) was 11.0 months in the CABOMETYX group and 1.9 months in the placebo group. The CABOMETYX group showed significant improvement in risk of disease progression and death, with an objective response rate of 18% in the CABOMETYX group compared to 0% in the placebo group.
The most common adverse events (≥25%) were diarrhea, hand-foot syndrome, fatigue, hypertension, and mouth ulcers, with an added warning regarding hypocalcemia.
The recommended dose of CABOMETYX is 60 mg once daily until disease progression or intolerable adverse effects. For pediatric patients [12 years and older with BSA <1.2 m²], the recommended dose is 40 mg once daily until disease progression or intolerable adverse effects.
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