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AstraZeneca's IMFINZI approved for Stage III nsclc
AstraZeneca's IMFINZI approved for Stage III nsclc.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 2013F AstraZeneca PLC 19 February 2018 \n\n \nThis announcement contains inside information\n \n19 February 2018 07:00 GMT\n \nUS FDA APPROVES IMFINZI FOR UNRESECTABLE STAGE III NON-SMALL CELL LUNG CANCER\n \nImfinzi is the only immunotherapy approved for patients with unresectable Stage III non-small cell lung cancer \n \nImfinzi showed an 11.2 month improvement in median progression-free survival (16.8 months compared to 5.6 months on placebo)\n \nAstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has approved Imfinzi for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT).\n \nDave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: \"The approval of Imfinzi in this earlier stage of non-small cell lung cancer is a truly meaningful milestone for patients who, until now, had no FDA-approved treatment options following chemoradiation therapy. Globally, approximately 30% of patients with NSCLC present with Stage III disease and we are excited to launch the first immunotherapy into this setting.\"\n \nScott J. Antonia, MD, Ph.D., Chair of the Thoracic Oncology Department at the H. Lee Moffitt Cancer Center and Research Institute in Tampa and investigator in the PACIFIC trial, said: \"Until now, treatment guidelines have recommended that patients with unresectable Stage III lung cancer undergo a period of active surveillance following chemoradiation therapy until disease progression. Given that up to 89% of patients will progress to metastatic disease, it is important that there is now a new option that can give patients more time without disease progression. The PACIFIC trial data supporting today's approval of Imfinzi will change how we treat these patients.\"\n \nThe approval of Imfinzi is based on the positive PFS data from the Phase III PACIFIC trial\nin which Imfinzi demonstrated an improvement in median PFS of 11.2 months compared to placebo, representing a 48% reduction in relative risk of progression or death vs. placebo in all patients, regardless of PD-L1 status. The PACIFIC tr...