SOUTH SAN FRANCISCO, Calif. (AP) — Drug developer Exelixis Inc. said Monday that the Food and Drug Administration has accepted its potential thyroid cancer treatment, carbozantinib, for priority review.
The drug aims to treat an advanced form of medullary thyroid cancer, and the South San Francisco, Calif., company said regulators are expected to make a decision on it by late November.
The FDA grants a priority review to products that, if approved, would meet an unmet medical need for a serious and life-threatening condition. The FDA aims to complete priority reviews in a shorter time frame than the usual 10 months for most drugs.
Exelixis said last fall patients who received the drug in a clinical trial had a median survival of more than 11 months before death or disease progression, compared to 4 months for patients who took the placebo. The improvement was greater than Exelixis expected.
Around 30,000 cases of medullary thyroid cancer are diagnosed every year in the U.S., or about 5 percent of all thyroid cancers.