AstraZeneca (AZN) recently announced that the US Food and Drug Administration (FDA) has extended the action date for the company’s cancer candidate, vandetanib, by three months. AstraZeneca is looking to get vandetanib approved for the treatment of non-operable (unresectable) locally advanced or metastatic medullary thyroid cancer (MTC).
The FDA extended the review period in order to evaluate a Risk Evaluation and Mitigation Strategy (REMS) submitted by AstraZeneca as per the agency’s requirements. The FDA will now deliver a decision regarding vandetanib’s approvability by April 7, 2011.
The FDA’s Oncologic Drugs Advisory Committee had met in December 2010 to review the vandetanib application. The advisory panel 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.
Earlier in 2010, 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.
The American Cancer Society estimates that more than 44,000 new cases of thyroid cancer were 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. Vandetanib is also under regulatory review in the EU.
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