New oral therapy is FDA approved for patients with non-small-cell lung cancer
Avella Specialty Pharmacy announced today that it will distribute TAGRISSO™ (osimertinib), a new FDA-approved therapy for patients with non-small cell lung cancer (NSCLC) with a specific type of gene mutation. TAGRISSO is indicated for use in patients with with metastatic EGFR T790M mutation-positive non-small cell lung cancer. EGFR is a protein found on the surface of cells that normally helps these cells divide. Mutations to this gene cause cancer cells to grow and spread rapidly. In addition, patients with the T790M mutation do not respond to EGFR kinase inhibitors—a class of drugs often used to treat lung cancer. This has traditionally led to limited treatment options for these individuals. With the introduction of TAGRISSO, these patients now have access to a once-a-day oral therapy that targets the genetic mutations responsible for both disease progression and treatment resistance.
The FDA approval of TAGRISSO is based on data from the two AURA Phase II studies (AURA extension and AURA2) which demonstrated efficacy in 411 EGFRm T790M NSCLC patients that had progressed on or after an EGFR TKI. In those trials, overall objective response rate ((ORR) a measurement of tumor shrinkage) was 59% (95% CI: 54% to 64%). In a separate part of the AURA Study in 63 patients, ORR was 51% and median duration of response was 12.4 months.
According to the American Cancer Society, lung cancer accounts for about 27 percent of all cancer deaths, making it the leading cause of cancer-related deaths in the US. NSCLC is the most common type of lung cancer and is frequently diagnosed in people who smoke.
“Thanks to the identification of new types of genetic mutations in patients with lung cancer, innovative therapies like TAGRISSO are now giving us more avenues to fight this disease than ever before,” said Leslie Yendro, RN, Vice President of Business Development for Avella Specialty Pharmacy. “Avella is very excited to be part of this movement through the distribution of TAGRISSO.”
Click here for complete TAGRISSO Prescribing Information.
About Avella Specialty Pharmacy
Headquartered in Phoenix, Arizona, Avella Specialty Pharmacy is a National Accredited Specialty Pharmacy, providing individualized care and support to patients since 1996. Avella's clinical pharmacists and staff members are experts in managing complex disease states and providing compassionate care. The company offers a nationwide distribution service to complement its retail locations. Avella reached 2,605th on Inc. Magazine's 2015 list of the 5,000 fastest-growing private companies in the country. In addition, the Arizona Corporate Excellence Awards has named Avella Specialty Pharmacy as the 2nd fastest-growing private company based in the state. For more information, please visit www.avella.com.