AstraZeneca receives EU nod for lung cancer drug Tagrisso

Global drug giant, AstraZeneca recently announced that the European Commission has granted marketing authorisation for Tagrisso (osimertinib) as monotherapy for the 1st-line treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. The approval is based on results from the Phase III FLAURA trial published in the New England Journal Of  Medicine

Mr Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: "Today’s approval is an exciting advance in bringing a potential new standard of care to patients with EGFR-mutated NSCLC in the EU. This milestone is also a step forward for our Company, marking another regional approval for Tagrisso in the 1st-line setting."

Dr. David Planchard, Associate Professor of Medicine, Head of Thoracic Group, Gustave Roussy cancer center, France said: "The FLAURA trial is changing medical practice in the 1st-line treatment of EGFR-mutated NSCLC. The progression-free survival benefit seen in the trial is unprecedented for patients with an EGFR mutation, and this benefit was consistent across all subgroups including in patients with or without central nervous system metastases. Further, the preliminary overall survival data, while not statistically significant at the time of the interim analysis, is promising, with a 37 percent reduction in the risk of death."

In the EU, Tagrisso is already indicated for the treatment of patients with locally-advanced or metastatic EGFR T790M mutation-positive NSCLC. Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths, more than breast, prostate and colorectal cancers combined. Approximately 10-15% of patients in the US and Europe, and 30-40% of patients in Asia have EGFR-mutated (EGFRm) NSCLC

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