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FDA extends review timeline for vandetanib new drug application

According to AstraZeneca, the FDA has extended the time to complete its review of the new drug application for the investigational drug vandetanib.

The company is seeking approval of vandetanib for the treatment of patients with unresectable locally advanced or metastatic medullary thyroid cancer. The drug is a once-daily selective oral inhibitor of RET, vascular endothelial growth factor receptor and epidermal growth factor receptor signaling.

As part of the review process, the FDA required that AstraZeneca submit a Risk Evaluation and Mitigation Strategy (REMS). A proposed REMS was submitted by the company, and the FDA accordingly extended the Prescription Drug User Fee Act (PDUFA) date from Jan. 7, 2011, to April 7, 2011.

In December 2010, the FDA’s Oncologic Drugs Advisory Committee voted 10-0 in favor of exploring additional dosing regimens or schedules for vandetanib. In addition, HemOnc Today reported in September that vandetanib 300 mg prolonged PFS in patients with medullary thyroid cancer as compared with placebo. The randomized, double blind, phase 3 ZETA study included 331 adults with unresectable locally advanced or metastatic medullary thyroid cancer.

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