AstraZeneca's Tagrisso secures Breakthrough Therapy Designation in first-line NSCLC

AstraZeneca has announced that its immunotherapy Tagrisso (osimertinib) has been awarded Breakthrough Therapy Designation by the FDA for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).

The decision of the US regulator was based on data generated from Phase 3 trials of the drug, the findings from which demonstrated that Tagrisso performed almost twice as well as standard of care EGFR TKI therapy in improving progression-free survival (PFS); in the trial, median PFS for Tagrisso stood at 18.9 months compared to 10.2 months for standard of care. These improvements were observed across all pre-specified sub-groups and the drug was well-tolerated in line with its known safety profile.   

The decision bodes well for a speedy approval of the drug, which is already approved in 50 countries, including the US – but only as a second-line option in that country. The new potential approval would bring Tagrisso’s use in line with the US National Comprehensive Cancer Network’s Clinical Practice Guidelines in Oncology, which now advises the use of the drug as a first line treatment in metastatic EGFR mutation-positive NSCLC, as updated on 28 September this year.

"The Breakthrough Therapy Designation acknowledges not only Tagrisso’s potential as a first-line standard of care in advanced EGFR mutation-positive NSCLC, but also the significant need for improved clinical outcomes in this disease," remarked Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca. "The results of the FLAURA trial have the potential to redefine clinical expectations and offer new hope for patients who currently have a poor prognosis."