November 13, 2015
2 min read

FDA approves Tagrisso for NSCLC

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact

The FDA today granted accelerated approval to osimertinib for the treatment of patients with T790M-mutated non–small cell lung cancer that has progressed after other epidermal growth factor receptor-blocking therapy.

Osimertinib (Tagrisso, AstraZeneca) is approved in conjunction with the cobas EGFR Mutation Test v2 (AstraZeneca), a companion diagnostic test designed to detect T790M, a specific EGFR mutation.

Lung cancer is the leading cause of cancer-related death in the U.S., according to a press release from the FDA. NSCLC is the most common form of lung cancer.

The FDA based its decision in part on the results of two multicenter, single-arm studies composed of a total of 411 patients with advanced, EGFR mutation-positive NSCLC whose disease progressed after initial EGFR-blocking treatment.

Fifty-seven percent of patients in the first study, as well as 61% of patients in the second study, experienced a complete or partial reduction in their tumor size with osimertinib.

The most commonly observed adverse events associated the osimertinib included diarrhea, dry skin, rash and infection. More serious adverse events, such as inflammation of the lungs and injury to the heart, may also occur.

Richard Pazdur, MD

Richard Pazdur

The FDA approved osimertinib under its accelerated approval program, which allows for the approval of a drug to treat a serious or life-threatening disease based on clinical data showing that the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit for patients while the manufacturer conducts confirmatory clinical trials. Osimertinib also had received breakthrough therapy designation, priority review and orphan drug designation.

“Our understanding of the molecular basis of lung cancer and reasons these cancers become resistant to prior treatments is rapidly evolving,” Richard Pazdur, MD, director of the office of hematology and oncology products in the FDA’s Center for Drug Evaluation and Research, said in the release. “This approval provides a new treatment for patients who test positive for the EGFR resistance mutation, T790M, and is based on substantial evidence from clinical trials that shows Tagrisso had a significant effect on reducing tumor size in over half of patients who were treated.”

The newly approved version of the cobas EGFR Mutation Test is the first companion diagnostic test to detect the T790M mutation.

“The approval of safe and effective companion diagnostic tests and drugs continue to be important developments in oncology,” Alberto Gutierrez, PhD, director of the office of in vitro diagnostics and radiological health in the FDA’s Center for Devices and Radiological Health, said in a press release. “The availability of the cobas EGFR Mutation Test v2 meets a need for the detection of this important EGFR gene mutation, which can alter treatment effectiveness.”