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Imfinzi Granted Breakthrough Therapy Designation By US FDA For Patients With Locally-Advanced Unresectable Non-Small Cell Lung Cancer

(AstraZeneca) July 31, 2017 - AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Imfinzi (durvalumab) for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.

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H. Jack West, MD (Posted: July 31, 2017)

quotesWe have learned from a press release that the PACIFIC trial is positive for a significant improvement in PFS after chemo/radiation for patients with locally advanced, unresectable NSCLC. Because this treatment entails an extra year of IV treatment every two weeks and a cost likely in the range of $180-200K per patient, most experts feel that the PFS benefit should be remarkably long and/or be accompanied by a significant improvement in survival. In this setting, demonstrating a 3-4 month delay in relapse without a survival benefit won't offset the cost in terms of time on treatment for patients or cost to society. The entire lung cancer community looks forward to the presentation of the actual trial data at an upcoming meeting -- I hope at ESMO 2017 (where I will be happy to provide commentary on the detailed findings). If the PACIFIC trial achieves these criteria, it should rightfully become adopted as a new standard of care in this setting. It would be ideal, however, if we can determine which patients are most or least likely to benefit from this extended treatment so that we can concentrate these extra efforts and costs on the patients who will truly benefit from them.quotes

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