Healthcare business AstraZeneca Plc (AZN,AZN.L) Wednesday said it has withdrawn the regulatory submissions for using Zactima, or vandetanib, 100mg in combination with chemotherapy in patients suffering from advanced non-small cell lung cancer, or NSCLC, from the US FDA and the European Medicines Agency, or EMEA.
The company specified that it decided to withdraw the submissions on the basis of an updated analysis, which exhibited no overall survival advantage when vandetanib was added to chemotherapy. Also, the decision was the outcome of preliminary feedback from regulatory agencies that the current package with progression-free survival, or PFS, as the primary endpoint may not be sufficient for approval.
According to the Phase III clinical trial results, vandetanib is clinically active when combined with chemotherapy. AstraZeneca noted that it will complete the ongoing Phase III trial programme, which is expected to provide a more complete view of efficiency of vandetanib in different clinical settings.
Vandetanib is an orally bioavailable 4-anilinoquinazoline. The drug has a unique profile that fights cancer through two clinically proven mechanisms, by blocking the development of tumour blood supply and by blocking the growth and survival of the tumour itself. Vandetanib also inhibits RET-tyrosine kinase activity, an important growth driver in certain types of thyroid cancer.
On May 31, 2009, Wall Street Journal reported that vandetanib or Zactima, can slow up the rate of lung-cancer growth in some patients with advanced lung cancer who had previously been treated with chemotherapy. The data was revealed at the American Society of Clinical Oncology's annual meeting.
The company submitted applications to the regulatory agencies in June 2009.
On July 30, 2009, AstraZeneca submitted New Drug Application to the U.S. Food and Drug Administration and a Marketing Authorisation Application, or MAA, to the European Medicines Agency or EMEA for the investigational drug vandetanib 100 mg for use in combination with chemotherapy for treating advanced NSCLC in patients previously treated with one prior anti-cancer therapy. In the announcement, the company specified that U.S. and European submissions were supported by data from Phase III clinical studies evaluating the safety and efficacy of vandetanib 100 mg in combination with chemotherapy. The treatment was named Zactima.
The company expects to report results from Zephyr, the 300mg monotherapy study in patients with advanced NSCLC, who formerly received an EGFR inhibitor, and Zeta, the 300 mg monotherapy in advanced medullary thyroid cancer, in late 2009 or early 2010.
Shares of AZN closed Tuesday's regular trade at $46.19, up $0.86, on a volume of 1.95 million shares.
AZN.L is currently trading at 2.83 pence, up 54.50 pence or 1.96%, on a volume of 4.57 million shares.
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