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The approval comes more than two months ahead of its PDUFA target date of December 4, 2021.
The FDA has approved Exelixis’ Cabometyx (cabozantinib) for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following treatment with a vascular endothelial growth factor receptor (VEGFR)-targeted therapy and who are resistant to radioactive iodine treatment.
This is more than two months ahead of the Prescription Drug User Fee Act (PDUFA) target action date of December 4, 2021. DTC is the most common type of thyroid cancer in the United States, and patients who are resistant to radioactive iodine treatment face a poor prognosis.
The approval is based on results from COSMIC-311, a phase 3 pivotal trial. At an interim analysis, Cabometyx reduce the risk of progression or death. At a follow-up analysis, the median progression-free survival was 11.0 months.
Serious adverse events seen in at least 5% of patients included hypertension, fatigue, diarrhea, and palmar-plantar erythrodysesthesia, which is a side effect that can cause redness, swelling, and pain in the hands and feet.
“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 S. Brose, M.D., Ph.D., chief, cancer center operation, Sidney Kimmel Cancer Center at Jefferson Torresdale Hospital, co-director, community based clinical trials, Sidney Kimmel Cancer Center at Thomas Jefferson University, and principal investigator of COSMIC-311, said in a statement.
In February 2021, the FDA granted Breakthrough Therapy Designation to Cabometyx for this indication.
Cabometyx is also approved for the treatment of patients with renal cell carcinoma (RCC), hepatocellular carcinoma who have been previously treated with Nexavar (sorafenib); and for patients with advanced RCC as a first-line treatment in combination with Opdivo (nivolumab).
The American Cancer Society estimates that 44,280 new cases of thyroid cancer will be diagnosed in the United States this year. Most (73%) of those cases will be in women. About 2,200 people will die from the disease.