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AstraZeneca: FDA Grants Breakthrough Therapy Designation For Tagrisso

Drug maker AstraZeneca (AZN,AZN.L) announced Monday that the US Food and Drug Administration has granted Breakthrough Therapy Designation or BTD for Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer or NSCLC.

The BTD was granted based on data from the Phase III FLAURA trial of Tagrisso versus standard-of-care EGFR tyrosine kinase inhibitor or TKI therapy in previously-untreated patients with locally-advanced or metastatic EGFR mutation-positive NSCLC.

In the trial, median progression-free survival was nearly double at 18.9 months for Tagrisso compared with 10.2 months for current 1st-line EGFR TKIs (erlotinib or gefitinib).

Improvements were seen in all pre-specified subgroups, including patients with and without brain metastases. Tagrisso was well tolerated with a safety profile consistent with previous experience.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, 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."

This is the sixth BTD that AstraZeneca has received from the FDA for an oncology medicine since 2014.

by RTT Staff Writer

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