The China Food and Drug Administration has granted marketing authorisation for Tagrisso, 40 mg and 80mg once-daily oral tablets for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer whose disease has progressed on or after EGFR tyrosine kinase inhibitor therapy.

“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,” said Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca.

Eligibility for treatment with Tagrisso requires the patient’s EGFR T790M mutation status to be determined with a validated test using either tumour DNA derived from a tissue sample or circulating tumour DNA (ctDNA) obtained from a plasma sample (blood test).

Tagrisso is the first AstraZeneca medicine approved under the CFDA’s Priority Review pathway, using an accelerated timeline for an innovative medicine.