Drug was fast-tracked by the FDA for use in treating advanced breast cancer
Avella Specialty Pharmacy announced today that it has been selected by Pfizer as one of the limited groups of specialty pharmacies authorized to distribute the manufacturer’s breakthrough breast cancer drug—Ibrance (palbociclib)—which has just received fast-tracked approval from the FDA.
Ibrance will be used in the treatment of postmenopausal women with estrogen receptor- positive, human epidermal growth factor receptor 2-negative metastatic breast cancer who have not yet received an endocrine-based therapy. It is to be used in combination with letrozole. Ibrance works by inhibiting molecules involved in promoting the growth of cancer cells.
The drug was approved under the FDA’s accelerated approval program which gives patients earlier access to promising new drugs while manufacturers conduct additional clinical trials. This type of approval is used for drugs intended to treat serious or life-threatening disease and where data shows a strong likelihood of clinical benefit for patients. The approval was based on data from a study on 165 postmenopausal women with this classification of metastatic breast who had not received previous treatment for the advanced disease. The study found that Ibrance stopped tumors from growing for a median of more than 20 months, about twice as long as current treatments. The drug also received a priority FDA review, which is an expedited review of drugs intended to provide a significant improvement in safety or effectiveness in the treatment of a serious condition or meet an unmet medical need. Full prescribing information can be found at www.ibrance.com.
“This rapid approval demonstrates that Ibrance has promising potential in improving outcomes for breast cancer patients,” said Leslie Yendro, RN, Vice President of Business Development for Avella Specialty Pharmacy. “Avella is incredibly proud to be able to extend access to this new drug to our patients.”
Breast cancer in women is the second most common type of cancer in the United States. The National Cancer Institute estimates that 232,670 American women were diagnosed with breast cancer and 40,000 died from the disease in 2014.
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 1,772th on Inc. magazine's 2014 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 fastest-growing private company based in the state. For more information, please visit www.avella.com.