FDA Approves New Drug for Some Patients with Non-Small Cell Lung Cancer

The FDA announced today it has approved a new pill to treat certain patients with advanced non-small cell lung cancer (NSCLC). The oral medication, Tagrisso (osimertinib), has been approved for NSCLC 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.

Pasi Janne, MD, PhD
Pasi A. Jänne MD, PhD

The new drug was tested through two clinical studies that involved 411 NSCLC patients with the specific EGFR mutation. Fifty-seven percent of patients in the first study and 61 percent of patients in the second study experienced complete or partial reduction in their tumor size.

“In the clinical studies, AZD9291 has demonstrated compelling early efficacy and tolerability in patients with the EGFR mutation T790M metastatic non-small cell lung cancer,” says Pasi A. Jänne MD, PhD, director of Dana-Farber’s Lowe Center for Thoracic Oncology. “This treatment has the potential to become the standard of care for patients living with EGFR mutation T790M non-small cell lung cancer.”

Dana-Farber researchers helped guide the approval for the drug, which was given “breakthrough therapy” designation by the FDA and approved under the agency’s accelerated approval program.

“The accelerated approval of AZD9291 highlights its clinical promise for a targeted group of patients and gives healthcare providers an important new option,” Jänne adds.

Tagrisso is one of several drugs recently approved for patients with advanced NSCLC; earlier this year, the FDA approved Iressa as a first-line treatment for patients with the disease.