Exelixis: no panel review of thyroid cancer drug
SOUTH SAN FRANCISCO, Calif. (AP) — Exelixis Inc. said Wednesday that a Food and Drug Administration advisory panel no longer plans to discuss its thyroid cancer drug cabozantinib at a meeting in November.
Exelixis said it has been informed that cabozantinib is no longer on the agenda for the Nov. 8 and 9 meeting of the FDA's oncological drugs advisory committee, which reviews cancer treatments. The FDA is conducting a six-month priority review of cabozantinib as a treatment for a type of advanced medullary thyroid cancer, and the agency is expected to make a decision on the drug by Nov. 29.
Cabozantinib is intended to treat cancer that is advanced, inoperable, or has metastasized.
The FDA's advisory panels conduct reviews of experimental drugs and make recommendations for or against their approval based on issues like effectiveness and safety. The agency is not required to follow the recommendations of its advisory committees, but it often does so. While a positive recommendation can improve the changes a drug will be approved, a negative review could hurt its chances.
Shares of Exelixis advanced 20 cents, or 4.6 percent, to $4.59 Wednesday, and then gained 25 cents, or 5.5 percent, to $4.84 in after-hours trading.