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The quality of life debate

FDA's skepticism about the quality of life data from AstraZeneca plc's Phase II trials of Iressa monotherapy was even stronger than its concerns about the failure of the company's Phase III trials in combination with chemotherapy. The agency twice rejected AZN's requests to use improvement on the Lung Cancer Subscale (LCS) of the Functional Assessment of Cancer Therapy for Lung Cancer as a co-primary endpoint, along with objective response rate.

FDA ultimately agreed to allow quality

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