AstraZeneca Reports Approval Of Tagrisso, Ultomiris & Lynparza In Japan

AstraZeneca PLC (AZN.L,AZN) said the company's Tagrisso (osimertinib) has been approved in Japan for the adjuvant treatment of patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer after surgery. The approval was based on positive results from the global ADAURA phase III trial. The company said Tagrisso is the only EGFR-targeted medicine approved in Japan for the treatment of early-stage lung cancer after surgery.

The company announced that Ultomiris (ravulizumab) has also been approved in Japan for the treatment of adult patients with generalised myasthenia gravis who are anti-acetylcholine receptor antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin therapy or plasmaphaeresis. Ultomiris can also be considered for patients who cannot receive high-dose IVIg or plasmaphaeresis due to complications, adverse reactions or other limiting factors.

Also, AstraZeneca and MSD's Lynparza (olaparib) has been approved in Japan for the adjuvant treatment of patients with BRCA-mutated, HER2-negative early breast cancer at high risk of recurrence. The company noted that Lynparza is the first and only approved medicine targeting BRCA mutations in early breast cancer.

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