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.