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Zactima Filing Withdrawn in US and Europe


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http://www.pharmafocus.com/cda/focusH/1 ... 24,00.html


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AstraZeneca withdraws filings for lung cancer drug

Monday , November 02, 2009

AstraZeneca has withdrawn marketing applications for its lung cancer drug Zactima in Europe and the US after evaluating updated results from clinical trials of the drug.

Zactima (vandetanib) was filed for approval in June for use as a second-line therapy, in combination with chemotherapy, in patients with advanced non-small cell lung cancer.

The compound has been pitched as an important new drug candidate for AstraZeneca, which needs a new generation of products to overcome upcoming patent expiries in its portfolio on drug such as gastrointestinal Nexium (esomeprazole), Seroquel (quetiapine) for schizophrenia and cholesterol-lowerer Crestor (rosuvastatin).

Just ahead of the marketing submissions, analysts at Jefferies Research had predicted peak sales of $400 million for Zactima in NSCLC and follow-up indication thyroid cancer.

The decision to pull the dossiers is based on an updated analysis of data from the ZODIAC, ZEAL and ZEST trials, which found no overall survival advantage when Zactima 100mg was added to chemotherapy in NSCLC patients.

News of the withdrawal did not come completely out of left field, as ZEAL and ZEST did not meet their primary endpoints and AstraZeneca's decision to press ahead with filing was considered a little speculative in some quarters.

The company had been hoping to secure approval for Zactima based on the drug's effectiveness in improving progression-free survival, but based on feedback from the regulatory authorities has concluded that this will not be sufficient to underpin marketing approval.

AstraZeneca now says it will press ahead with two other phase III clinical trials of the drug - the ZEPHYR study looking at its use as a monotherapy in NSCLC and the ZETA study in advanced medullary thyroid cancer - in order to "give a more complete view of vandetanib efficacy in different clinical settings".

Results of these trials are not due until next year.

Vandetanib is designed to tackle cancer in a multitude of ways. It blocks the development of a tumour's blood supply by inhibiting vascular endothelial growth factor (VEGF), which is the same target as Roche's blockbuster cancer drug Avastin (bevacizumab).

In addition, AstraZeneca's compound restricts the growth and survival of the tumour by targeting epidermal growth factor (EGF), and directly inhibits intracellular processes, such as RET-tyrosine kinase activity, which are implicated in a number of cancers, including thyroid cancer.

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(PharmaFocus.com, news, November 2, 2009)


The information contained in these articles may or may not be in agreement with my own opinions. They are not being posted with the intention of being medical advice of any kind.

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