AstraZeneca's lung cancer drug fast-tracked for first-line treatment

The US drug regulator has given AstraZeneca's osimertinib treatment for patients with advanced metastatic non-small cell lung cancer 'breakthrough therapy designation' to fast-track its becoming a first-line treatment.

By granting BTD status to the drug, which is branded Tagrisso, the Food and Drug Administration will expedite the regulatory review of the medicines as a first-line treatment for standard of care in advanced epidermal growth factor receptor mutation-positive NSCLC.

Tagrisso has already received FDA approval but, while the US National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology were updated to include the use of Tagrisso as a first-line treatment for this form of lung cancer, the FDA is yet to bump it up from second-line status.

The BTD status follows the FTSE 100 company's Phase III Flaura trial, which increased the median progression-free survival for previously-untreated patients to 18.9 months versus 10.1 from the current first-line treatments, erlotinib or gefitinib.

Astra's chief medical officer, Sean Bohen said: "The Breakthrough Therapy Designation acknowledges not only Tagrisso's potential as a 1st-line standard of care in advanced EGFR mutation-positive NSCLC, but also the significant need for improved clinical outcomes in this disease. 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."