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AstraZeneca: cancer treatment approved by EU

(CercleFinance.com) - The group announces that Tagrisso with the addition of chemotherapy has been approved by the European Union (EU) as a new 1st-line treatment for patients with EGFR-mutated advanced lung cancer.


The European Commission's approval follows a positive opinion from the Committee for Medicinal Products for Human Use, and is based on the results of the phase III FLAURA2 trial published in The New England Journal of Medicine.

In the trial, Tagrisso in combination with chemotherapy reduced the risk of disease progression or death by 38%, as assessed by the investigator, compared to Tagrisso monotherapy, which is the global standard of care for first-line treatment.

Median progression-free survival (PFS) was 25.5 months for patients treated with Tagrisso plus chemotherapy, an 8.8-month improvement over Tagrisso monotherapy (16.7 months).


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