AstraZeneca drug gets FDA Breakthrough status

AstraZeneca photo.

AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation forTagrisso(osimertinib) for the 1st-line treatment of patients with an advanced type of lung cancer.

Sean Bohen, executive vice president, Global Medicines Development and chief medical officer at AstraZeneca, said: “The Breakthrough Therapy Designation acknowledges not onlyTagrisso’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.”

In the trial, median progression-free survival was nearly double at 18.9 months forTagrisso 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.Tagrissowas well tolerated.

The use ofTagrissofor the 1st-line treatment of patients with locally-advanced or metastatic EGFR mutation-positive NSCLC is not yet FDA approved.


However,Tagrissois currently approved in more than 50 countries, including the US, EU, Japan and China, as a 2nd-line treatment for a type of advanced lung cancer.

AstraZeneca employs about 1,500 in Delaware.

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