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China Approves AstraZeneca's Tagrisso To Treat Early-stage Lung Cancer

British drug major AstraZeneca Plc. (AZN,AZN.L) said Wednesday that the China has approved the company's Tagrisso or osimertinib for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated or EGFRm non-small cell lung cancer or NSCLC after tumour resection with curative intent, with or without adjuvant chemotherapy as recommended by the patient's physician.

Tagrisso is indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 (L858R) mutations.

The approval was based on results from the ADAURA Phase III trial where Tagrisso reduced the risk of disease recurrence or death by 80%.

Tagrisso is approved to treat early-stage lung cancer in more than a dozen countries, including the US, and additional global regulatory reviews are ongoing.

Tagrisso is also approved for the 1st-line treatment of patients with locally advanced or metastatic EGFRm non-small cell lung cancer and for the treatment of locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer in China, and in the US, Japan, the EU and many other countries.

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