3rd Feb 2025 08:34
(Alliance News) - AstraZeneca PLC on Monday said Imfinzi has been recommended for approval in the EU as monotherapy for limited-stage small cell lung cancer.
The Committee for Medicinal Products for Human Use of the European Medicines Agency based its positive opinion on the results from the Adriatic Phase III trial, which were published in the New England Journal of Medicine.
These results showed Imfinzi reduced the risk of death by 27% versus placebo. The estimated median overall survival was 55.9 months for Imfinzi versus 33.4 months for placebo. An estimated 57% of patients treated with Imfinzi were alive at three years compared to 48% for placebo.
Susan Galbraith, executive vice president, Oncology Haematology, R&D, AstraZeneca, said: "With 57% of patients still alive at three years in the Adriatic 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."
The safety profile for Imfinzi was consistent with the known profile of this medicine. No new safety signals were observed.
Imfinzi is approved in the US and several other countries in this setting based on the Adriatic results. Regulatory applications are currently under review in Japan and several other countries in this indication.
Shares in AstraZeneca were 0.6% lower at 11,274.00 pence in London on Monday morning. The wider FTSE 100 was down 1.2%.
By Jeremy Cutler, Alliance News reporter
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