Why did AstraZeneca pull regulatory submissions for its experimental cancer drug Zactima?”
AstraZeneca PLC said Wednesday it has withdrawn applications for regulatory approval for its lung cancer drug Zactima following disappointing trial results. The pharmaceutical company had been seeking regulatory clearance in the United States and European Union to use Zactima — generic name vandetanib — in combination with chemotherapy for treating advanced non-small cell lung cancer. “The decision to withdraw these submissions was based on an updated analysis that demonstrated no overall survival advantage when vandetanib was added to chemotherapy,” the company said. Regulators had also hinted that the results were insufficient for approval, the company added. AstraZeneca said it will complete a trial program which is expected to give more results on the efficacy of the drug in difference clinical settings. AstraZeneca shares were down 1 percent at 2,800 pence on the London Stock Exchange.
UPDATE 2-AstraZeneca pulls submissions for lung cancer drug Wed Oct 28, 2009 4:39am EDT * Withdraws Zactima plus chemo in non-small cell lung cancer * Analysis shows no overall survival benefit * Blow to pipeline, though Phase III tests will continue * Shares down 1.5 percent (Adds shares, sales expectations, background) By Ben Hirschler LONDON, Oct 28 (Reuters) – AstraZeneca (AZN.L: Quote, Profile, Research, Stock Buzz) has pulled regulatory submissions for its experimental drug Zactima plus chemotherapy as a treatment for lung cancer, dealing a blow to its new product pipeline and hitting its shares. It had filed the combination as a treatment for advanced non-small cell lung cancer (NSCLC) with U.S. and European authorities in June, and previously highlighted Zactima as an important new submission for 2009. The decision to withdraw the filings follows an updated clinical analysis that demonstrated no overall survival advantage when Zactima, also known as vandetanib, was added to che
AstraZeneca has pulled regulatory submissions for its experimental drug Zactima plus chemotherapy as a treatment for lung cancer, dealing a blow to its new product pipeline and hitting its shares. It had filed the combination as a treatment for advanced non-small cell lung cancer (NSCLC) with U.S. and European authorities in June, and previously highlighted Zactima as an important new submission for 2009. The decision to withdraw the filings follows an updated clinical analysis that demonstrated no overall survival advantage when Zactima, also known as vandetanib, was added to chemotherapy, the Anglo-Swedish drugmaker said on Wednesday.
