Pfizer-Ibrance-FDA-Approval2

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This week the U.S. Food and Drug Administration (FDA) approved a new drug to treat postmenopausal women with advanced breast cancer who have not already taken other drugs. Ibrance by Pfizer Inc. is to be used in combination with Letrozole, another drug used to treat certain kinds of breast cancer in postmenopausal women. Pfizer said the drug is available to order immediately through specialty pharmacies.

In a press release by the FDA, “Ibrance works by inhibiting molecules, known as cyclin-dependent kinases (CDKs) 4 and 6, involved in promoting the growth of cancer cells. Ibrance 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 an endocrine-based therapy. It is to be used in combination with letrozole, another FDA-approved product used to treat certain kinds of breast cancer in postmenopausal women.”

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 based the approval in part on results of a phase 2 study that included 165 postmenopausal women with ER-positive, HER-2–negative advanced breast cancer. Researchers assigned patients to Femara with or without Ibrance.

Common side effects associated with Ibrance includes neutropenia, leukopenia, fatigue, anemia, upper respiratory infection, nausea, stomatitis, alopecia, diarrhea, thrombocytopenia, decreased appetite, vomiting, asthenia, peripheral neuropathy and epistaxis.

About the FDA
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.