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FDA approves osimertinib (Tagrisso) for first-line treatment of metastatic NSCLC with most common EGFR mutations

AstraZeneca’s Tagrisso has been approved in the US as a first-line treatment for patients with metastatic non-small-cell lung cancer whose tumours have epidermal growth factor receptor (EGFR) mutations.

The drug is already cleared in the US as a second-line treatment for this subgroup of lung cancer patients, whose disease progressed on or after a first-line EGFR-TKI therapy and who have developed the secondary T790M mutation.

The expanded approval is based on data from the Phase III FLAURA trial, in which Tagrisso (osimertinib) significantly boosted progression-free survival (PFS) compared to current first-line EGFR-TKIs, erlotinib or gefitinib, in previously-untreated patients with the condition.

According to the data, progression free survival in patients taking Tagrisso was 18.9 months compared to 10.2 months for those receiving the standard of care, while the objective response rate was 80 percent versus 76 percent, respectively.

“Tagrisso delivered unprecedented median progression-free survival data across all pre-specified patient subgroups, including patients with or without CNS metastases, and could prolong the lives of more patients without their tumours growing or spreading,” noted Dave Fredrickson, head of AstraZeneca’s Oncology Business Unit.

A new analysis of FLAURA results presented at the European Lung Cancer Conference (ELCC) in Geneva also showed that the drug’s PFS benefit over EGFR tyrosine kinase inhibitors (TKIs) was sustained throughout post-progression outcomes.


Tagrisso is also under regulatory review in the European Union and Japan for use in the first-line treatment setting with regulatory decisions anticipated in the second half of 2018.

The most common adverse reactions (occurring in at least 20% of patients treated with osimertinib) were diarrhea, rash, dry skin, nail toxicity, stomatitis, and decreased appetite. Serious adverse reactions were reported in 4% of patients treated with osimertinib. The most common serious adverse reactions (≥1%) were pneumonia (2.9%), ILD/pneumonitis (2.1%), and pulmonary embolism (1.8%).

The recommended dose of osimertinib is 80 mg orally once daily, with or without food.

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