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The PDUFA date has been set for December 4, 2021; FDA has designated this as a Priority Review.
The FDA has accepted the sNDA for Exelixis' Cabometyx (cabozantinib) for treatment for patients 12 years and older with differentiated thyroid cancer (DTC) who have progressed following prior therapy and are radioactive iodine-refractory.
The FDA granted Priority Review designation and assigned a PDUFA target action date of December 4, 2021.
The application is based on the results of COSMIC-311, a phase 3 pivotal trial, that found that Cabometyx met one of the trial’s primary end points. At a planned interim analysis, the therapy demonstrated a significant reduction in the risk of disease progression or death of 78% versus placebo.
Findings were presented at the 2021 American Society of Clinical Oncology and were later published by The Lancet Oncology in July 21, 2021.
In February 2021, the FDA granted Breakthrough Therapy Designation to Cabometyx for this indication.
Cabometyx is 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 (32,130; 73%) of those cases will be in women. About 2,200 people will die from the disease. The deaths from thyroid cancer are more evenly distributed between men and women (1,050 deaths among men in 2021 compared with 1,150 deaths among women).