The U.S. Food and Drug Administration today granted accelerated approval to Ibrance (palbociclib) to treat advanced (metastatic) breast cancer.
Breast cancer in women is one of the three common cancers in most countries.
The drug, whose chemical name is palbociclib, was approved for previously untreated postmenopausal women whose cancer cells have receptors to the female hormone estrogen and who do not have mutations in the HER2 gene that can contribute to uncontrolled growth of breast cells. Such patients represent the largest proportion of breast cancer cases and are typically treated with the chemotherapy tamoxifen or letrozole, a drug used to prevent production of estrogen.
It works through a new mechanism of action, by blocking two enzymes involved in cell division, CDK4 and CDK6. In one clinical trial, the average patient taking Ibrance in combination with the standard treatment letrozole went 20.2 months without a worsening of symptoms - twice the length of time of those taking letrozole alone.
The most common side effects of the drug were a decrease in infection-fighting white blood cells called neutrophils (neutropenia), low levels of white blood cells (leukopenia), fatigue, low red blood cell counts (anemia), upper respiratory infection, nausea, inflammation of the lining of the mouth (stomatitis), hair loss (alopecia), diarrhea, low blood platelet counts (thrombocytopenia), decreased appetite, vomiting, lack of energy and strength (asthenia), damage to the peripheral nerves (peripheral neuropathy) and nosebleed (epistaxis). Healthcare professionals should inform patients of these risks.
Pfizer said it would price Ibrance at $9,850 a month, or $118,200 per year. The company noted that most prescriptions are dispensed through health plans, which negotiate discounts for medicines or get government-mandated price concessions.
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm432871.htm
