AstraZeneca wins approval in China for early-stage lung cancer treatment Tagrisso

AstraZeneca PLC (LON:AZN) said its prescription medicine Tagrisso (osimertinib) was approved in China for the adjuvant treatment of patients with early-stage lung cancer.

It is aimed at patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who have had surgery to remove the tumour, and can be used with or without chemotherapy as recommended by the patient’s physician.

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The approval by China’s National Medical Products Administration (NMPA) was based on positive results from the ADAURA Phase III trial.

While up to 30% of all patients with NSCLC may be diagnosed early enough to have surgery with curative intent, recurrence is still common in early-stage disease, the FTSE 100 company said.

Historically, nearly half of patients diagnosed in Stage IB, and over three-quarters of patients diagnosed in Stage IIIA, have experienced recurrence within five years.

More than a third of the world’s lung cancer patients are in China and among those with NSCLC, approximately 40% have tumours with an EGFR mutation, the pharma giant added.

“The expedited approval of Tagrisso in China as part of a curative-intent regimen for early-stage EGFR-mutated lung cancer underscores the high unmet need in this setting and our commitment to improving outcomes in a country with one of the highest rates of EGFR mutations in the world,” said Dave Fredrickson, executive vice president of the firm’s oncology business unit.

“This approval reinforces the importance of EGFR testing across all stages of lung cancer, prior to treatment decisions, to ensure as many patients as possible can benefit from targeted therapies like Tagrisso and live cancer-free longer.”

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.