07:21 AM EDT, 06/25/2024 (MT Newswires) -- AstraZeneca ( AZN ) said Tuesday that Tagrisso with the addition of chemotherapy has been approved in Japan for the first-line treatment of adult patients with epidermal growth factor receptor-mutated non-small cell lung cancer.

The approval by the Japanese Pharmaceuticals and Medical Device Agency was based on results from the FLAURA2 phase III trial, the company said.

Results of the trial showed that Tagrisso with the addition of chemotherapy decreased the risk of disease progression or death by 38% by investigator assessment compared with Tagrisso monotherapy, which is the first-line global standard of care.

The median progression-free survival was 25.5 months for patients treated with Tagrisso plus chemotherapy, an 8.8-month improvement versus Tagrisso monotherapy, the company added.

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