For immediate release:

Today, the U.S. Food and Drug Administration approved Tagrisso (osimertinib) as the first diagnostic treatment for patients with non-small cell lung cancer, who have tumors with a specific type of genetic predisposition.

“Today’s endorsement of Tagrisso demonstrates how further research into treatments approved at later stages can improve cancer treatment options for patients at earlier stages,” said Richard Pazdur, MD, director of the Center of Excellence FDA Oncology and the executive director of the Office of Oncologic Diseases at the FDA’s Drug Assessment and Research Center. “With this license, patients can be treated with this targeted treatment at an earlier and potentially more curative level of non-small cell lung cancer.”

Lung cancer is the most common type of cancer and the leading cause of cancer-related deaths worldwide. In the U.S., approximately 229,000 adults will be diagnosed with lung cancer by 2020, and 76% of cases will be non-small cell lung cancer. Approximately 20% of patients with non-small cell lung cancer have epidermal growth factor receptor (EGFR) mutations, which are mutations in proteins that cause rapid cell growth, and as a result, help with cancer spread. Although the majority of patients who are diagnosed with non-small cell lung cancer have non-small cell lung cancer, 30% have recurrent disease; thus, more than 10,000 patients nationwide can be candidates for Tagrisso as a diagnostic treatment after tumor removal. Tagrisso was approved in 2018 for the first-line treatment of patients with non-small metastatic lung cancer who have tumors with removal of EGFR exon 19 or exon 21 L858R mutations.

Tagrisso was evaluated in a randomized, double-blind, placebo-controlled trial of 682 patients with early-stage non-small cell lung cancer and EGFR exon 19 or exon 21 L858R mutation-positive through complete tumor removal. A total of 339 patients received oral Tagrisso once daily and 343 received placebo after undergoing routine conventional surgery and chemotherapy, if prescribed. The main outcome measure was the time it took for cancer to recur or for death to occur from any cause (disease-free survival). In the overall trial population, patients who received Tagrisso had an 80% reduction in risk of recurrence compared with patients who received placebo.

The most common side effects of Tagrisso include diarrhea, rash, muscle aches, dry skin, swelling of the skin around nails, sore mouth, fatigue and cough. Tagrisso should be delayed if patients develop symptoms of interstitial lung disease, and should be stopped permanently if interstitial lung disease is diagnosed. Tagrisso can affect the heart’s electrical system and can also cause issues such as heart failure so it should be checked periodically. Tagrisso can also cause inflammation in the cornea. Tagrisso can cause fetal damage when given to a pregnant woman; therefore, the pregnancy status of women of childbearing potential should be determined before starting treatment with Tagrisso. Tagrisso should be withheld if Stevens-Johnson syndrome or erythema multiforme major is suspected.

Tagrisso received an orphan drug assignment for the treatment of EGFR mutation-positive or non-small cell lung cancer. Orphan drug assignment provides an incentive to aid and encourage drug development for rare diseases. In addition, the organization assigned Tagrisso Therapy Breakthrough for this signal.

The FDA approved Tagrisso to AstraZeneca.

This review was conducted under Project Orbis, an initiative of the FDA’s Center for Excellence in Oncology. The Orbis Project provides a framework for the application and review of oncology drugs among international partners. For this review, the FDA collaborated with the Australian Therapeutic Product Administration, the Brazilian Health Regulatory Agency, Health Canada, the Health Sciences Authority of Singapore and Swissmedic Switzerland. The application reviews are ongoing at the other regulatory bodies.

The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by determining the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for use. human, and medical devices. The organization is also responsible for the safety and security of our country’s food supply, cosmetics, dietary products, products that emit electronic radiation, and for the regulation of tobacco products.


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