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Imfinzi approved in US for small cell lung cancer
Imfinzi approved in US for small cell lung cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n RNS Number : 0052I\n AstraZeneca PLC\n 30 March 2020\n \n \n \n 30 March 2020 07:00 BST\n \n \n \n Imfinzi \n \n \n approved in the US \n \n \n for \n \n \n extensive-stage small cell lung cancer\n \n \n \n \n \n \n Only PD-1/PD-L1 immunotherapy to demonstrate a significant survival benefit in combination with etoposide and a choice of carboplatin or cisplatin chemotherapy\n \n \n \n \n \n AstraZeneca's Imfinzi (durvalumab) has been approved in the US as a 1st-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care (SoC) chemotherapies, etoposide plus either carboplatin or cisplatin (platinum-etoposide).\n \n \n \n \n \n The approval by \n the Food and Drug Administration \n was based on positive results from the Phase III CASPIAN trial \n showing \n \n Imfinzi\n \n in combination with SoC platinum-etoposide demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus SoC alone.\n \n \n \n \n \n SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy\n .1,2\n \n \n \n \n \n Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: \"The US approval of Imfinzi brings a new medicine to extensive-stage small cell lung cancer patients in urgent need of new options. Imfinzi is the only immunotherapy to show both a significant survival benefit and improved response rate in combination with chemotherapy for these patients, an important step forward in treating this devastating disease.\"\n \n \n \n \n \n Jonathan Goldman, MD, Associate Professor of Hematology & Oncology, UCLA Medical Center, Santa Monica, California and a lead investigator in the Phase III CASPIAN trial, said: \"Patients with extensive-stage small cell lung cancer continue to face a poor prognosis, and finding new medicines to improve outcomes in this setting has been a formidable challenge. The CASPIAN trial enables clinicians to choose durvalumab in combination with etoposide and either carboplatin or cisplatin, making this an important new 1st-line treatment option for patients that is both effective and well-tolerated.\"\n \n \n \n \n \n The Phase III CASPIAN trial had two pri...