Tagrisso Approved by FDA to Treat Certain Forms of Lung Cancer
The Food and Drug Administration (FDA) is issuing an approval for a drug that will provide those suffering from advanced non-small cell lung cancer (NSCLC) with a new treatment option.
The agency has announced that it will approve Tagrisso (osimertinib) for use in patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy.
"Our understanding of the molecular basis of lung cancer and reasons these cancers become resistant to prior treatments is rapidly evolving," Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a written statement. "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 efficacy of Tagrisso was demonstrated in two studies with a total of 411 patients. In these two studies, 57 percent of patients in the first study and 61 percent of patients in the second study experienced a complete or partial reduction in their tumor size (known as objective response rate).
The FDA granted several designations to Tagrisso that will enable the drug to reach the market on an expedited schedule. These include breakthrough therapy, priority review, orphan drug, and accelerated approval designation.
The most common side effects of Tagrisso are diarrhea, skin and nail conditions such as dry skin, rash and infection or redness around the fingernails. Tagrisso may cause serious side effects, including inflammation of the lungs and injury to the heart. It also may cause harm to a developing fetus.
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.