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AstraZeneca PLC said China's National Medical Products Administration granted marketing authorization for the company's drug Tagrisso to treat non-small cell lung cancer.
Tagrisso, also called osimertinib, can now be used in China as an initial treatment for adults with NSCLC that has spread to nearby tissues or lymph nodes, or to a different body part. These patients' tumors harbor exon 19 deletions or exon 21 substitution mutations in the epidermal growth factor receptor gene.
The approval was based on results from a late-stage study, dubbed Flaura, which showed Tagrisso significantly increased the length of time patients survived with the disease compared to AstraZeneca's other medicine, Iressa, or Roche Holding AG's drug Tarceva. Tagrisso was assessed under the Chinese regulator's priority review pathway.
China approved Tagrisso in March 2017 and added it to the country's National Reimbursement Drug List starting January 2019 for the 2nd-line treatment of certain adults with locally advanced or metastatic NSCLC.
Tagrisso has received approval in 75 countries, including the U.S., Japan, China and the EU, for the initial treatment of advanced NSCLC, and in 84 countries for the 2nd-line treatment of NSCLC. Tagrisso is expected to become the U.K. drugmaker's best-selling drug in 2019.

