FDA fast-tracked approval of this breakthrough therapy for a specific type of genetic blood cancer
Phoenix, AZ — Avella Specialty Pharmacy announced today that it has been selected by pharmaceutical manufacturer AbbVie to dispense Venclexta (venetoclax), the first therapy in its class to win FDA approval. Venclexta is an oral, once-daily drug indicated for use in chronic lymphocytic leukemia (CLL) patients who lack a portion of a chromosome that thwarts cancer growth. This abnormality is referred to as a 17p deletion and it occurs in approximately 10 to 20 percent of patients with this type of blood cancer. Traditionally, these CLL patients were more difficult to treat and had less favorable outcomes than other patients with the condition. Venclexta is indicated for the treatment of patients with CLL with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.
Venclexta uses a novel mechanism of action, targeting BCL-2, a protein that promotes cancer growth. This protein is often overabundant in people with CLL. The drug triggers a natural process that drives cancer cells to self-destruct. Venclexta's effectiveness was tested in clinical studies involving 106 people with CLL who also had the 17p deletion abnormality. After receiving the drug over a five-week period, 80 percent of trial participants showed a complete or partial remission.
The FDA recognized the importance of this new therapy early on, speeding its time to market through a breakthrough therapy designation, priority review status and accelerated approval. Venclexta also received orphan drug designation from the FDA.
“Thanks to our ability to provide this innovative therapy, patients with CLL who possess this genetic abnormality now have access to another powerful treatment option,” said Leslie Yendro, RN, Vice President of Business Development for Avella Specialty Pharmacy. “Our distribution of the latest breakthrough oral oncolytics is just one of the ways that Avella is supporting the delivery of comprehensive care.”
CLL is one of the most common types of leukemia in adults. It occurs when the bone marrow makes abnormal white blood cells which then enter the bloodstream. This process begins slowly and many patients don’t have symptoms for several years. In the meantime, these cancer cells can easily spread to lymph nodes and vital organs. Chronic leukemia is also generally harder to treat than acute forms of leukemia. Approximately 15,000 new cases of CLL are diagnosed in the U.S. every year.
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 and was named America’s fastest-growing woman-led company in 2015. In addition, the Arizona Corporate Excellence Awards named Avella Specialty Pharmacy as the second fastest-growing private company based in the state in 2015. For more information, please visit www.avella.com.