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FDA OKs Imfinzi for unresectable stage III NSCLC, 5/18

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May 2018—AstraZeneca and MedImmune, its biologics research and development arm, announced the FDA has approved Imfinzi (durvalumab) for the treatment of patients with unresectable stage III non-small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

Approval of Imfinzi is based on the positive progression-free survival data from the phase three PACIFIC trial, in which Imfinzi demonstrated an improvement in median PFS of 16.8 months compared with 5.6 months on placebo, representing a 48 percent reduction in relative risk of progression or death versus placebo in all patients, regardless of PD-L1 status. The PACIFIC trial is ongoing to evaluate overall survival in unresectable stage III NSCLC. Detailed interim results of the PACIFIC trial were published in the New England Journal of Medicine (Antonia SJ, et al. 2017;377[20]:1919–1929).

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