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FDA Approves Tagrisso for Certain Patients With Non–Small-Cell Lung Cancer

New diagnostic test identifies specific gene mutation targeted by new drug

The FDA has granted accelerated approval for an oral medication to treat patients with advanced non–small-cell lung cancer (NSCLC). Osimertinib (Tagrisso, AztraZeneca)  is approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has worsened after treatment with other EGFR-blocking therapy.

Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, according to the National Cancer Institute. The most common type of lung cancer, NSCLC occurs when cancer cells form in the tissues of the lung. EGFR is a protein involved in the growth and spread of cancer cells.

“Our understanding of the molecular basis of lung cancer and reasons these cancers become resistant to prior treatments is rapidly evolving,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “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 osimertinib had a significant effect on reducing tumor size in over half of patients who were treated.” 

The FDA also approved the first companion diagnostic test (cobas EGFR Mutation Test v2) to detect the type of EGFR resistance mutation that osimertinib is known to target. The newly approved version of the test adds the T790M mutation to the clinically relevant mutations detected by the original cobas EGFR Mutation Test.

The safety and efficacy of osimertinib were demonstrated in two multicenter, single-arm studies involving 411 patients with advanced EGFR T790M mutation-positive NSCLC whose disease worsened after treatment with an EGFR-blocking medication. In these studies, 57% of patients in the first study and 61% of patients in the second study experienced a complete or partial reduction in tumor size (the objective response rate). Continued approval for this indication may be contingent upon confirmatory studies.

The most common side effects of osimertinib are diarrhea and skin and nail conditions, such as dry skin, rash, and infection or redness around the fingernails. Osimertinib may cause serious side effects, including inflammation of the lungs and injury to the heart. It also may harm a developing fetus.

The FDA granted AstraZeneca breakthrough therapy designation, priority review, and orphan drug designation for osimertinib, which was approved under the agency’s accelerated approval program. That allows the approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients.

Source: FDA, November 16, 2015.

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