FDA approves AstraZeneca’s Tagrisso

WILMINGTON, Del. — AstraZeneca on Friday announced that the Food and Drug Administration had approved the company’s Tagrisso (osimertinib) tablets. The once-daily 80-mg tablets are indicated for patients with metastatic non-small cell lung cancer that is mutation positive for the epidermal growth factor receptor T790M. 

 

The drug was granted Fast Track, Breakthrough, Priority Review and Accelerated Approval status by the FDA and has shown an objective response rate of 59% with a median duration of about 12.4 months. 

 

“The FDA approval of Tagrisso marks an important milestone for lung cancer patients who urgently need new treatment options,” AstraZeneca CEO Pascal Soriot said. “We have built on our heritage in this area and acted on the breakthrough clinical evidence to ensure this next-generation medicine reaches patients in record time.”