AstraZeneca's lung cancer treatment recommended for approval in EU

Tagrisso, otherwise known as osimertinib, was given a positive opinion by the Committee for Medicinal Products for Human Use of the European Medicines Agency following positive results from the FLAURA2 phase three trial, recently published in The New England Journal of Medicine.

Non-small cell lung cancer is the most common for of lung cancer, with 10-15% of patients across Europe having tumours with an epidermal growth factor receptor (EGFR) mutation – something that Tagrisso targets.

Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy. The treatment is already approved as monotherapy in more than 100 countries.

Median progression-free survival was 25.5 months for patients treated with Tagrisso plus chemotherapy, compared with 16.7 months on Tagrisso monotherapy.

Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, said: "Today's news reinforces the importance of Tagrisso as the backbone therapy in EGFR-mutated lung cancer.

"If approved in Europe, patients will have the option to be treated with Tagrisso alone, or with chemotherapy, which is especially important when caring for patients whose disease has spread to the brain or those with L858R mutations."