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AstraZeneca's Tagrisso nabs full US FDA approval for lung cancer drug

The U.S. FDA granted full approval to AstraZeneca PLC's lung cancer drug, Tagrisso.

Tagrisso is the first approved treatment in the U.S. for patients with non-small cell lung cancer who tested positive for a T790M mutation in the epidermal growth factor receptor gene.

The full approval is based on data from the company's phase 3 clinical trial, which showed Tagrisso improving progression-free survival to 10.1 months, compared to 4.4 months with chemotherapy treatment.

The once-daily tablet was first approved in the U.S. on Nov. 13, 2015, under the FDA's accelerated approval process.

The drug secured marketing approval from the China FDA a week ago.