Tagrisso (osimertinib) EU-godkänt i första linjen vid NSCLC

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The EU approves Tagrisso for 1st-line treatment of EGFR-mutated non-small cell lung cancer

1st-line Tagrisso offers a potential new standard of care

Today 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.

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.”

The approval follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.


Safety data for Tagrisso from the FLAURA, AURA3, AURA and AURA2 trials were evaluated. Tagrisso was well tolerated, with most adverse reactions Grade 1 or 2 in severity. In all patients, the most common adverse reactions were decreased leucocytes (68% [1.5% Grade ≥3]), decreased lymphocytes (67% [7.2% Grade ≥3]), decreased platelet count (54% [1.6% Grade ≥3]), diarrhoea (49% [1.2% Grade ≥3]), rash (47% [0.9% Grade ≥3]), decreased neutrophils (35% [4.1% Grade ≥3]), dry skin (33% [0.1% Grade ≥3]), paronychia (31% [0.3% Grade ≥3]), stomatitis (20% [0.2% Grade ≥3]), and pruritus (17% [0.1% Grade ≥3]).

In the EU, Tagrisso is already indicated for the treatment of patients with locally-advanced or metastatic EGFR T790M mutation-positive NSCLC. Today’s approval follows the recent approvals of Tagrisso for the 1st-line treatment of patients with metastatic EGFR-mutated (EGFRm) NSCLC in the US, Brazil and the Russian Federation. Tagrisso is also under regulatory review in Japan for use in the 1st-line treatment setting with a decision anticipated in the second half of 2018, with other global health authority reviews and submissions ongoing.