AstraZeneca (AZN) recently announced the outcome of the review of its cancer candidate, vandetanib, by an advisory panel of the US Food and Drug Administration (FDA). AstraZeneca is looking to get vandetanib approved for the treatment of non-operable (unresectable) locally advanced or metastatic medullary thyroid cancer (MTC).
The FDA’s Oncologic Drugs Advisory Committee was asked to discuss whether vandetanib should be used only in patients with progressive, symptomatic MTC. The panel was also asked to evaluate whether it would be more suitable to use vandetanib in certain subgroups based on the risk-benefit profile.
The panel said that there are certain MTC patients for whom vandetanib’s risk-benefit profile is acceptable. The panel voted 10-0 in favor of conducting a post-marketing study for other doses of the drug.
Encouraging Data on Vandetanib
Earlier this year, AstraZeneca had presented encouraging phase III data on vandetanib. Data showed that treatment with vandetanib resulted in a 54% reduction in the rate of disease progression compared to placebo.
In addition to achieving the primary endpoint of progression-free survival, vandetanib also showed improvement compared to placebo in the secondary endpoints, which were objective response rate and disease control rate. AstraZeneca reported that the response rate in the vandetanib arm was 45%.
The randomized, double-blind, placebo-controlled, multi-center study ZETA was conducted in 331 patients suffering from advanced MTC. Common adverse events included rash, diarrhea, hypertension, nausea and headache.
According to the American Cancer Society, more than 44,000 new cases of thyroid cancer are expected to be diagnosed in 2010 in the US. Medullary tumors account for 4% of all thyroid cancers.
We note that AstraZeneca has previously experienced failure with its development plans for vandetanib. In June 2009, AstraZeneca had filed for approval of vandetanib for its use along with chemotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC).
However, AstraZeneca had to withdraw the regulatory submissions from both the US and the EU as an updated analysis of results showed no overall survival advantage when vandetanib was added to chemotherapy. Moreover, the regulatory authorities had indicated that the data submitted by AstraZeneca might not be sufficient for approval.
Neutral on AstraZeneca
We currently have a ‘Neutral’ recommendation on AstraZeneca, which is supported by a Zacks #3 Rank (short-term “Hold” recommendation). Although the market for medullary thyroid cancer may not be huge, vandetanib, once approved, should be able to capture a significant share of the market as no approved treatments are currently available. A response from the FDA should be out by January 7, 2011. Vandetanib is also under regulatory review in the EU.
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