AstraZeneca (AZN) recently announced that its regulatory application for pipeline candidate, vandetanib, has been accepted for review by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The company is looking to get vandetanib approved for the treatment of advanced medullary thyroid cancer (MTC).
In addition to accepting the regulatory submission, the FDA also granted priority review status to AstraZeneca for the drug. This means that the FDA will review the application within six months of submission instead of the usual ten months. A response from the agency regarding the approvability of vandetanib should be out by Jan 7, 2011.
Encouraging Data Presented at ASCO
Earlier this year, AstraZeneca had presented encouraging phase III data on vandetanib at the annual meeting of the American Society of Clinical Oncology (ASCO). 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. The incidence is higher in Europe with more than 50,000 cases each year. Medullary tumors account for 5% 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.
Our Recommendation
We currently have a Zacks #2 Rank (short-term Buy rating) on AstraZeneca, given the June 29, 2010, favorable court ruling on Crestor’s US patent, which was upheld and validated until 2016. This proved to be a major win for the company, as was the FDA Advisory Committee’s positive recommendation for the approval of Brilinta.
Longer-term, we have a Neutral recommendation on AstraZeneca. 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.
ASTRAZENECA PLC (AZN): Free Stock Analysis Report
Zacks Investment Research
