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Oncology medicine Tagrisso granted breakthrough therapy designation by FDA

The US Food and Drug Administration (FDA) has granted breakthrough therapy (BTD) designation to the AstraZeneca drug Tagrisso (osimertinib).  It is the sixth such designation granted to AstraZeneca oncology medicine since 2014. Tagrisso received BTD for first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation positive non-small cell lung cancer (NSCLC). 

A Phase III trial of the protein kinase inhibitor's efficacy in comparison to standard-of-care EGFR tyrosine kinase inhibitor therapy in patients who had yet to receive treatment for locally advanced or metastatic EGFR mutation positive NDCLC. The trial revealed progression-free survival was nearly twice as long in patients taking Tagrisso. 

Sean Bohen, executive vice-president, global medicines development, and chief medical officer at AstraZeneca, commented: "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."

The breakthrough therapy designation granted by the FDA is also an acknowledgment of the potential of Tagrisso as a first-line standard of care, he added, observing that it also highlights the "the significant need for improved clinical outcomes in this disease".

Common side effects of Tagrisso include diarrhea, rash, dry skin, changes to nails (such s redness, tenderness, and pain), and tiredness. Other potential side effects of the medication include lung problems, heart problems, heart failure, and eye problems. Before taking Tagrisso, patients should inform their doctor if they have lung or breathing problems, heart problems, a history of eye problems or electrolyte issues. Pregnant women or those planning to become pregnant should also avoid the medicine.

Lung cancer is the leading cause of cancer death in American patients, accounting for approximately one-quarter of cancer deaths in men and women, according the Center for Disease Control and Prevention (CDC). In 2017, there were more 222,500 new cases of lung cancer diagnosed in the United States and 155,870 deaths as a result of the disease, figures from the American Cancer Society. 

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