FDA Fast Tracks New Drug for Metastatic Breast Cancer
On Feb. 3, 2015, the Food and Drug administration announced that it had quickly approved a new drug from Pfizer called Ibrance Palbociclib. The drug is used alongside letrozole to treat women with metastatic breast cancer who have not yet undergone endocrine-based therapy.
The new treatment comes in pill form and is the first hormone-based therapy to treat postmenopausal women with estrogen receptor positive, human epidermal growth factor receptor 2 negative advanced breast cancer. It is to be used alongside letrozole, another tablet prescription that fights breast cancer in women who have already undergone menopause. Ibrance is a cyclin-dependent kinase inhibitor, which reduces the potential for growth of cancerous cells.
According to Forbes, The FDA has approved several new drugs for Her2+ cancers, but treatment options for breast cancers that are hormone-sensitive have been significantly less present on the approval list.
The side effects of the new drug include a decrease in white blood cells, fatigue, upper respiratory infection, vomiting, damage to the peripheral nerves, nosebleed, hair loss, decreased appetite and diarrhea. Pfizer recommends that doctors strictly monitor the patient’s white blood cell count while on the medication. Recommended treatment includes a 125 milligram dose for 21 days and then seven days without the medicine.
Breast cancer is the second biggest killer of women in the U.S. and the National Cancer Institute found that 40,000 American women died from the disease in 2014. The new treatment was approved two months ahead of time through the FDA’s accelerated approval program because it showed so much promise in treating the disease. In a randomized trial with Ibrance, the progression-free survival rate of women with metastatic breast cancer went from 10.2 to 20.2 months. These numbers moved the medicine to the advanced approval program.