AstraZeneca debuts vandetanib for medullary thyroid cancer in USA

Anglo-Swedish drug major AstraZeneca (LSE: AZN) said yesterday that its orphan drug vandetanib is now available to US 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 US Food and Drug Administration earlier this month (The Pharma Letter April 7) and is available exclusively through the pharmacy business unit of Biologics, an integrated oncology management company.

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 support vandetanib patients and prescribers, Biologics says it has designed an innovative program focused on rapid access to treatment while establishing a more efficient and controlled distribution channel to help meet AstraZeneca’s REMS requirements.