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AstraZeneca on the front foot after US FDA speeds up process for Imfinzi lung cancer drug

05:18 EDT 31 Jul 2017 | Proactive Investors

AstraZeneca plc (LON:AZN) shares gained after saying the US Food and Drug Administration has agreed to speed up the process required for a development and regulatory review of its new lung cancer drug Imfinzi. The regulator has granted breakthrough therapy designation, designed to accelerate the review of new medicines for treating serious conditions that have demonstrated encouraging early clinical results.  This is usually awarded when the results show substantial improvement on a clinically-significant endpoint over available medicines and when there is significant unmet medical need. In May, the pharmaceutical company announced positive interim results from the Phase III Pacific trial of Imfinzi as sequential treatment in patients with stage III non-small cell lung cancer, who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy. “Imfinzi is the first immuno-oncology medicine to show a clinically-significant benefit in this earlier, non-metastatic setting, so following the Breakthrough Designation we hope to bring it to patients as soon as possible,” Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said alongside today’s announcement. Shares in AstraZeneca rose 1.44% to 4,547.50p. The progress in Imfinzi comes in contrast to a failed Phase II trial of lung cancer treatment, Mystic, last Thursday, which saw billions wiped of the company’s value. The study did not meet the primary end point of improving progression-free survival compared to chemotherapy. READ: Billions wiped off AstraZeneca’s value as key lung cancer study fails to meet primary endpoint

Original Article: AstraZeneca on the front foot after US FDA speeds up process for Imfinzi lung cancer drug

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