FDA Approves Cabometyx to Treat Differentiated Thyroid Cancer


In a phase 3 trial, the medication significantly reduced the risk of disease progression compared with individuals in a placebo group.

Exelixis Inc, said the FDA has approved its Cabometyx (carbozantinib)medication for the treatment of individuals aged 12 years or older with locally advanced or metastatic differentiated thyroid cancer (DTC) that progressed following prior vascular endothelial growth factor receptor (VEGFR) targeted therapy and who are resistant to radioactive iodine-refractory or ineligible.

“Before today, patients with radioactive iodine-refractory differentiated thyroid cancer who have progressed following prior VEGFR-targeted therapy were facing aggressive disease and no standard treatment option,” Marcia Brose, MD, PhD, chief at Cancer Center Operation Sidney Kimmel Cancer Center at Jefferson Torresdale Hospital, co-director at Community Based Clinical Trials at Sidney Kimmel Cancer Center at Thomas Jefferson University, and principal investigator of COSMIC-311, said in a statement.

“In the COSMIC-311 pivotal phase 3 trial, Cabometyx extended the time patients live without progression of their cancer,” she said. "The FDA approval of Cabometyx is an important advancement for these patients who are badly in need of new treatment options.”

The results from the COSMIC-311 phase 3 pivotal trial showed that Cabometyx significantly reduced the risk of disease progression or death compared with the placebo in individuals with radio iodine-refractory DTC that progressed after up to 2 prior VEGFR-target therapies.

A follow-up analysis, with a median of 10.1 months, showed the median progression-free survival was 11 months for individuals treated with Cabometyx compared with 1.9 months for individuals treated with the placebo.

Common adverse events were reported in 25% of individuals treated with Cabometyx and included diarrhea, fatigue, hypertension, palmar-plantar erythrodysesthesia, and stomatitis.

The FDA granted Breakthrough Therapy designation and Priority Review to the drug, and its approval is more than 2 months ahead of the target action date of December 4, 2021.

The results of the COSMIC-311 trial were presented at the 2021 European Society of Medical Oncology Congress on September 16 through the 21.


Exelixis announces US FDA approval CABOMETYX (carbozantinib) for patients with previously treated radioactive iodine-refractory differentiated thyroid cancer. Business Wire. News release. September 17, 2021. Accessed September 20, 2021. https://www.businesswire.com/news/home/20210917005517/en

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