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

0

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 (osimetinib), 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.

Make An Appointment

For adults: 877-960-1562

Quick access: Appointments as soon as the next day for new adult patients

For children: 888-733-4662

All content in these blogs is provided by independent writers and does not represent the opinions or advice of Dana-Farber Cancer Institute or its partners.

Latest Tweets

Dana-Farber @danafarber
Dr. Matthew Davids explores combining ibrutinib with FCR (iFCR) for younger patients with previously-untreated chro… https://t.co/wzVpo47tSa
Dana-Farber @danafarber
“We’re changing the way people are cared for, through #precisionmedicine, precision care, and a total team approach… https://t.co/RnZXsH2rW8
Dana-Farber @danafarber
Cell-weighing method could help doctors choose #cancer drugs: https://t.co/YesjtyxIvR via @MIT https://t.co/0F7wsZSuLJ

Republish our posts on your blog

Interested in sharing one of our stories on your blog? Feel free to republish this content! We just ask that you credit Dana-Farber, link to the original article, and refrain from making edits that change the original context. Questions? Email the editors at insight_blog@dfci.harvard.edu.