Exelixis Gets FDA Priority Review of Cabometyx in Differentiated Thyroid Cancer

By Colin Kellaher

Exelixis Inc. on Thursday said the U.S. Food and Drug Administration granted priority review to its application for expanded approval of its cancer drug Cabometyx in certain people with differentiated thyroid cancer.

The Alameda, Calif., biopharmaceutical company said the application covers patients 12 years and older who have progressed following prior therapy and are radioactive iodine-refractory.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. Exelixis said the agency set a target action date of Dec. 4 for the new indication.

Exelixis said differentiated thyroid tumors make up about 90% of cases of cancerous thyroid tumors, adding that about 44,000 new cases of thyroid cancer will be diagnosed in the U.S. this year.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

August 05, 2021 08:38 ET (12:38 GMT)

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