AstraZeneca grabs expanded ok for Tagrisso

April 19, 2018

The U.S. FDA has approved AstraZeneca’s cancer-drug, Tagrisso, for the first-line treatment of patients with metastatic non-small cell lung cancer.

The approval is based on results from the Phase III FLAURA trial, which were presented at the European Society of Medical Oncology 2017 Congress and published in the New England Journal of Medicine. Trial results demonstrated that Tagrisso could cut the risk of disease progression or death by 54 percent when up off against current 1st-line EGFR tyrosine kinase inhibitors (TKIs) — Roche’s Tarceva and AstraZeneca’s own Iressa.

Up to this point, Tagrisso has been limited to second-line patients with EGFR T790M mutation. The drug generated sales of $955 million in 2017.

Read the press release