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AstraZeneca's key lung cancer treatment wins US approval


AstraZeneca's key lung cancer treatment wins US approvalAstraZeneca received a boost on Friday evening, after US regulators approved expanded use of its immunotherapy drug, Imfinzi, for lung cancer. The drug is the same one which last summer prompted more than £10bn to be wiped off the market value of AstraZeneca, after a trial showed it failed to improve progression free survival in lung cancer patients compared to using chemotherapy. However, that trial had been testing for more advanced stage four lung cancer patients. The approval AstraZeneca received on Friday related to stage three lung cancer patients, with the US Food & Drug Administration saying its approval was based on a randomised trial of 713 patients whose cancer had not progressed after completing chemotherapy and radiation. Those patients taking Imfinzi during the trial had a progression-free survival period, meaning the period in which their tumours did not significantly grow, that was three times longer than those receiving a placebo. AstraZeneca's application was granted priority review and breakthrough therapy designations by the FDA.  The regulator had previously already approved the drug for bladder cancer patients. It will come as a welcome boost to AstraZeneca, who had been hoping the Imfinzi drug would help it stake its claim in the fast-growing immuno-oncology drugs market. Lung cancer is currently the largest area of unmet patient need, being the leading cause of cancer death in the US and resulting in over 150,000 deaths in the US alone last year, according to the FDA. The poor Mystic trial results last year dented AstraZeneca's ambitions, although it later released full data for two successful lung cancer drug trials. More comprehensive overall survival rates from the Mystic trial are expected later this year. 





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