07:12 AM EST, 11/18/2024 (MT Newswires) -- AstraZeneca ( AZN ) said Monday that its drug Tagrisso has been recommended for approval in the European Union for the treatment of adult patients with locally advanced, inoperable non-small cell lung cancer with specific tumor types.
The European Medicines Agency's Committee for Medicinal Products for Human Use recommended the drug also known as osimertinib in patients whose whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy.
The recommendation was based on results from a Phase 3 trial in which the drug reduced the risk of disease progression or death by 84% compared with a placebo, the company said. Median progression-free survival was 39.1 months in patients treated with Tagrisso compared with 5.6 months for a placebo, the company said.