Advisors to the US Food and Drug Administration have recommended use of AstraZeneca’s vandetanib to treat a rare type of thyroid cancer, although they are concerned about dosage.
The agency’s Oncologic Drugs Advisory Committee discussed the New Drug Application for vandetanib for the treatment of patients with non-operable locally advanced or metastatic medullary thyroid cancer. The panel was asked to consider whether the indication should be limited to patients with progressive, symptomatic MTC and comment on whether there are any other subgroups that may be appropriate for treatment with vandetanib in light of the risk-benefit profile.
The committee was not asked to vote on the latter but did acknowledge that there are patients with MTC in which the risk-benefit profile of vandetanib was acceptable. They then voted 10 to 0 in favour of a post-approval study requirement to evaluate other doses.
The review was based on the results of ZETA, a Phase III study designed to evaluate vandetanib compared to placebo. MTC accounts for 4% of all thyroid cancers, and it is estimated that more than 44,000 new cases of the latter will be diagnosed in the USA in 2010.
AstraZeneca chief medical officer Howard Hutchinson noted that there is no drug approved to treat MTC and on the ZETA findings, “we believe it has the potential to provide appropriate patients and their doctors with an important treatment option”.
A final decision is due by January 7 for vandetanib, which was previously studied as a treatment for advanced non-small cell lung cancer in combination with chemotherapy. However, AstraZeneca withdrew an application to the FDA and the European Medicines Agency in October 2009 after an updated analysis demonstrated no overall survival advantage.
