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The FDA evaluated Gilotrif under its priority review programme and based its approval on a study of 345 participants with metastatic NSCLC whose tumours harboured EGFR mutations. Participants were randomly assigned to receive Gilotrif or up to six cycles of the chemotherapy drugs pemetrexed and cisplatin and the data showed that the Boehringer drug had a delay in tumor growth (progression-free survival) that was 4.2 months later than those receiving chemotherapy. There was no statistically significant difference in overall survival.
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