AstraZeneca's medicine approved under China’s Priority Review

AstraZeneca has been boosted by the news that its drug, Tagrisso, has become its first drug to be approved under China’s new Priority Review pathway. The approval comes in a particular indication of non-small cell lung cancer (NSCLC) and opens further avenues for AstraZeneca’s into the lung cancer market in China, with its drug Iressa already on the market.

The particular indication for which the drug has been approved is in adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

It is particularly good news for AstraZeneca because Tagrisso targets those patients who have epidermal growth factor receptor mutated tumours – a particular subset of patients which is higher in proportion in Asia. Some 30% to 40% of patients in Asia have this abnormality and this could see China become one of the biggest markets for the drug.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "This is an important step forward for Tagrisso and a significant opportunity to bring a breakthrough medicine to patients with NSCLC in China, where EGFR mutation rates are some of the highest in the world."

The Chinese market clearly represents, as Bohen notes, an opportunity for Western companies to reach the second largest market in the world. China, for its part, is mooting changes to drug approvals that would see Western drugs have a quicker route of getting to market. Particularly it would mean that the International Multicenter Clinical Trials would be given a key role in putting drugs through their paces, rather than relying initially on Western trials. The process would speed access for patients to get their hands on Western drugs, with quicker approvals.

This change comes as demand for drugs grows in China, with a high population and the public receiving better quality healthcare, there is more demand than ever for treatments.

Ben Hargreaves