Content about Vandetanib

November 30, 2012

The Food and Drug Administration has approved a new drug made by Exelixis for treating thyroid cancer, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Exelixis for treating thyroid cancer, the agency said.

The FDA announced the approval of Cometriq (cabozatinib) to treat medullary thyroid cancer — a cancer that develops in cells in the thyroid gland that make calcitonin, a hormone that helps maintain a healthy level of calcium in the blood — that has spread to other parts of the body. Another drug to treat medullary thyroid cancer, AstraZeneca's Caprelsa (vandetanib), was approved last year.

April 25, 2011

Anglo-Swedish drug maker AstraZeneca has made the drug vandetanib available to certain thyroid cancer patients.

WILMINGTON, Del. — Anglo-Swedish drug maker AstraZeneca has made the drug vandetanib available to certain thyroid cancer patients.

The drug maker announced Monday that the drug would be available to patients with medullary thyroid cancer that could not be removed surgically or that had spread to other parts of the body. The Food and Drug Administration approved the drug on April 6, and it is available exclusively through the pharmacy business unit of Biologics Inc., an integrated cancer management company.

April 7, 2011

The Food and Drug Administration has approved a drug made by AstraZeneca for treating a rare form of thyroid cancer, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by AstraZeneca for treating a rare form of thyroid cancer, the agency said.

The FDA announced the approval of the daily pill vandetanib for late-stage medullary thyroid cancer in patients whose disease is growing and causing symptoms but who are ineligible for surgery.

Medullary thyroid cancer involves specific cells found in the thyroid gland and can occur spontaneously or be part of a genetic disease. There currently are no FDA-approved treatments for this cancer.

January 17, 2011

A new drug application for Anglo-Swedish drug maker AstraZeneca's vandetanib has been extended.

LONDON — A new drug application for Anglo-Swedish drug maker AstraZeneca's vandetanib has been extended.

The drug maker recently announced that the Food and Drug Administration asked AstraZeneca to submit a Risk Evaluation and Mitigation Strategy, which accordingly extended the Prescription Drug User Fee Act from Jan. 7 to April 7.

AstraZeneca will continue to work closely with the FDA to support the review of vandetanib, a drug for treating patients with advanced medullary thyroid cancer.

September 22, 2010

The Food and Drug Administration has accepted AstraZeneca’s regulatory application for an investigational cancer drug,...

LONDON The Food and Drug Administration has accepted AstraZeneca’s regulatory application for an investigational cancer drug, the Anglo-Swedish drug maker said Thursday.

 

AstraZeneca announced the FDA’s acceptance of its application for vandetanib, a drug for treating patients with advanced medullary thyroid cancer. The agency gave the drug priority review status and expected to take action on it in January.