Apr 25 2011
AstraZeneca (NYSE: AZN) today announced that the orphan drug vandetanib is now available to U.S. patients for the treatment of medullary thyroid cancer that cannot be removed by surgery or that has spread to other parts of the body. Vandetanib was approved by the U.S. Food and Drug Administration on April 6, 2011 and is available exclusively through the pharmacy business unit of Biologics, Inc., an integrated oncology management company.
“Vandetanib is the only medicine specifically approved for patients with this rare form of cancer”
Vandetanib is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable (non-operable) locally advanced or metastatic disease. The use of vandetanib in patients with indolent, asymptomatic or slowly progressing disease should be carefully considered because of the treatment-related risks.
A Risk Evaluation and Mitigation Strategy (REMS) is required for vandetanib due to the risks of QT prolongation, Torsades de pointes, and sudden death. Only prescribers who are certified through the Vandetanib REMS Program, a restricted distribution program, will be able to prescribe vandetanib. To learn about the specific REMS requirements and to enroll in the Vandetanib REMS Program, health care professionals should call 1-800-236-9933 or visit www.vandetanibrems.com.
"Vandetanib is the only medicine specifically approved for patients with this rare form of cancer," said Lisa Schoenberg, Vice President of Specialty Care, AstraZeneca. "We believe vandetanib will be important for the community of patients and doctors who are fighting this disease."
AstraZeneca is working with relevant authorities on a trade name and is currently referring to the treatment by its generic name, vandetanib.
SOURCE AstraZeneca
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