AstraZeneca's Imfinzi set for go-ahead by EU to treat lung cancer
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AstraZeneca's Imfinzi has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy.
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The Committee for Medicinal Products for Human Use of the European Medicines Agency based its positive opinion on the results from the ADRIATIC Phase 3 trial which showed Imfinzi reduced the risk of death by 27% versus placebo. An estimated 57% of patients treated with the drug were alive at three years compared to 48% for placebo.
Susan Galbraith, the company’s executive vice-president of oncology haematology research and development said: "With 57% of patients still alive at three years in the trial, Imfinzi has the potential to transform treatment for people with limited-stage small cell lung cancer.”
“If approved, these patients will have access to immunotherapy for the first time, redefining expectations of survival outcomes in this setting."
Reporting by Frank Prenesti for Sharecast.com