Pfizer’s Ibrance (palbociclib) inhibits molecules that play a role in the growth of cancer cells. It is intended for postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have not yet received endocrine-based therapy, the FDA said.
Ibrance is to be used in combination with letrozole, another drug used to treat certain kinds of breast cancer in postmenopausal women, the agency said.
“The addition of palbociclib to letrozole provides a novel treatment option to women diagnosed with metastatic breast cancer,” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in an agency news release.
Ibrance was approved under the FDA’s accelerated approval program, which provides patients with earlier access to promising new drugs while the manufacturer conducts further clinical trials to confirm the medicine’s safety and effectiveness.
The FDA’s approval of Ibrance was based on a study that included 165 postmenopausal women who had ER-positive, HER2-negative advanced breast cancer and had not been treated for their advanced disease.
Those who received Ibrance plus letrozole lived about 20 months without their disease progressing, compared to about 10 months for those who took only letrozole. Data on overall survival rates is not yet available.
Common side effects of Ibrance include low white and red blood cell counts, fatigue, nausea, upper respiratory infection, diarrhea, vomiting, hair loss, inflammation of the lining of the mouth, decreased appetite, nosebleeds, and damage to the nerves in the extremities, the agency said.
The U.S. National Cancer Institute has more on breast cancer.
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