LONDON (dpa-AFX) - AstraZeneca (AZN.L, AZN) said that its Imfinzi has been recommended by the Committee for Medicinal Products for Human Use or CHMP for marketing authorisation in the European Union for the 1st-line treatment of adults with extensive-stage small cell lung cancer in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin.
The Committee for Medicinal Products for Human Use of the European Medicines Agency based its positive opinion on results from the Phase III CASPIAN trial for Imfinzi plus chemotherapy.
The trial showed that Imfinzi plus chemotherapy demonstrated a statistically significant and clinically meaningful overall survival benefit for the 1st-line treatment of patients with ES-SCLC, reducing the risk of death by 27% versus chemotherapy alone. Results also showed an increased confirmed objective response rate in the Imfinzi plus chemotherapy arm and that Imfinzi added to chemotherapy delayed the time it took for lung cancer-related symptoms to worsen.
Small cell lung cancer is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy.
Imfinzi in combination with etoposide and either carboplatin or cisplatin is approved in the US and several other countries around the world for the treatment of ES-SCLC in the 1st-line setting and is currently under regulatory review in Japan and other countries.
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