AstraZeneca: cancer treatment approved by the 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).

Dave Fredrickson, Executive Vice President of AstraZeneca's Oncology Business Unit, said: ' This approval reinforces Tagrisso as a core treatment for EGFR-mutated lung cancer, either as monotherapy or in combination with chemotherapy. This is particularly important for people with more aggressive disease, including patients whose cancer has spread to the brain and those with L858R mutations'.

Copyright (c) 2024 CercleFinance.com. All rights reserved.