The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended AstraZeneca’s Imfinzi (durvalumab) for approval in the European Union (EU) as a single agent for limited-stage small cell lung cancer (LS-SCLC).
Imfinzi is indicated for the adult population whose condition has not progressed after platinum-based chemoradiation therapy.
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The recommendation is based on the positive outcomes from the Phase III ADRIATIC trial.
The therapy minimised mortality risk by 27% against a placebo. It also showed a 24% decrease in disease progression or mortality risk.
The therapy’s safety profile was generally manageable and consistent with its known characteristics, with no new safety concerns identified.
Imfinzi received approvals in the US and other nations based on the ADRIATIC trial outcomes for this setting.
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By GlobalDataRegulatory reviews are ongoing for the same indication in Japan and other nations.
The trial comprised 164 centres across 19 nations in Europe, Asia and North and South America.
It compared the therapy as a single agent and in conjunction with Imjudo (tremelimumab) against a placebo in LS-SCLC subjects who did not progress following chemoradiation therapy.
AstraZeneca research and development oncology haematology executive vice-president Susan Galbraith stated: “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.”
Imfinzi is part of a broad development programme, being tested alone and in conjunction with other treatments across various cancer types.
The company’s previous lung cancer treatments, Tagrisso and Imfinzi, received recommendations from England’s National Institute for Health and Care Excellence for use within England and Wales’s National Health Service.
