5th Dec 2024 09:46
(Alliance News) - AstraZeneca PLC on Thursday said the US Food & Drug Administration has approved its Imfinzi treatment for adults with limited-stage small cell lung cancer.
The Cambridge-based pharmaceuticals company said the approval was granted after Imfinzi, or durvalumab, had secured priority review and breakthrough therapy designation, based on results from the Adriatic phase III trial.
The treatment is particularly aimed at patients whose disease has not progressed after concurrent platinum-based chemotherapy and radiation therapy.
Small cell lung cancer typically recurs and progresses rapidly, with only 15% to 30% of patients still alive five years after diagnosis.
Imfinzi reduced the risk of death by 27% compared to a placebo in the Adriatic trial. An estimated 57% of patients were still alive three years on, compared to 48% for the placebo.
Dave Fredrickson, executive vice president of AstraZeneca's oncology business unit, said: "This approval for Imfinzi marks a breakthrough for patients with limited-stage small cell lung cancer, allowing them to receive immunotherapy for the first time. The Adriatic trial showed an improvement in median overall survival of 22.5 months, setting a new benchmark. Imfinzi is now the only immunotherapy approved for both limited- and extensive-stage small cell lung cancer, underscoring our commitment to improving survival rates."
Imfinzi is also currently approved in Switzerland, with further regulatory applications under review in the EU and Japan.
Shares in AstraZeneca were up 0.4% at 10,526.00p each in London on Thursday morning.
By Emily Parsons, Alliance News reporter
Comments and questions to [email protected]
Copyright 2024 Alliance News Ltd. All Rights Reserved.
Related Shares:
Astrazeneca