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12:00 AM
Sep 30, 2002
 |  BioCentury  |  Product Development

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 of life as a co-primary endpoint, but it cautioned the company that "it is your task to demonstrate that the symptom findings are credible in a single arm study and are clinically significant. Correlation with objective response may be helpful in this regard," according to minutes of an August 2000 meeting.

The protocol specified that to be considered as having "disease-related symptom improvement," a patient had to sustain a 2-point or more improvement in total LCS...

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