FDA approves AstraZeneca drug for advanced lung cancer
WASHINGTON - The Food and Drug Administration has approved a new drug from AstraZeneca for patients with lung cancer that has spread despite earlier treatments.
The daily pill, Tagrisso, is intended for patients whose tumors have a genetic mutation that affects their growth.
Regulators approved the drug based on two studies of about 400 people that showed roughly 60 percent of patients treated with the drug had a partial or complete reduction of their tumor size.
The drug was approved under the FDA's accelerated approval program, which grants streamlined market access based on promising early-stage results.
The FDA also approved an accompanying diagnostic to test for the mutation that Tagrisso targets.
Lung cancer is the most deadly form of cancer in the U.S., with an estimated 158,000 deaths expected in 2015.