China’s Food and Drug Administration (CFDA) approved AstraZeneca’s lung cancer drug Tagrisso® (osimertinib) as a treatment for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer (NSCLC) that has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.

The U.K. drug maker said Tagrisso is the first of its drugs to be cleared under the CFDA’s new Priority Review pathway. Sean Bohen, M.D., Ph.D., evp for Global Medicines Development and CMO 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.”

Tagrisso is a once-daily, central nervous system (CNS)-active, oral EGFR inhibitor designed to inhibit both EGFR sensitizing and T790M resistance mutations. The drug was granted accelerated FDA approval for the EGFR T790M mutation-positive NSCLC indication in November 2015, and was cleared in Europe in February 2016, and in Japan during March.

Tagrisso has to date been approved in more than 45 countries and achieved achieved global sales of $423 million in 2016. In mid-2016, AstraZeneca reported positive data from the Phase I BLOOM study evaluating osimertinib in patients with leptomeningeal disease, a complication of EGFR mutation-positive advanced NSCLC.

AstraZeneca maintains China is its second largest global market, generating revenues of $2.6 billion in 2016. The firm has more than 11,000 employees in China, with headquarters in Shanghai and facilities for discovery through to clinical development R&D and commercial manufacturing.

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