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AstraZeneca's Tagrisso gets EU approval as standalone lung cancer treatment

AstraZeneca PLC said the European Commission approved Tagrisso as a standalone initial treatment for adult patients with a certain type of lung cancer.

The drug was granted marketing authorization for non-small cell lung cancer, or NSCLC, that has advanced or spread to other parts of the body and exhibits mutations related to epidermal growth factor receptor, or EGFR — a protein associated with cell division.

The approval is based on a phase 3 study, called Flaura, which showed Tagrisso kept the disease at bay for a median of 18.9 months compared to 10.2 months for patients given Roche Holding AG's Tarceva and AstraZeneca's Iressa.

Based on preliminary data, Tagrisso also reduced the risk of death by 37% compared to the Tarceva and Iressa, although the benefit was not statistically significant at the time of the interim analysis, said David Planchard, associate professor of medicine at Gustave Roussy cancer center, France.

The European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval of the drug in April.

Tagrisso gained the U.S. Food and Drug Administration's approval as an initial treatment for this type of cancer in April and is undergoing review in Japan, with a decision expected in the second half of 2018.

Lung cancer is the leading cause of cancer death, with about 10% to 15% of patients in the U.S. and Europe and 30% to 40% of patients in Asia having EGFR-mutated NSCLC.