The U.S. Food and Drug Administration has approved a drug developed by Novartis (NYSE: NVS) for advanced breast cancer in post-menopausal women. The Swiss pharmaceutical company’s drug has been approved to be used in combination with Aromasin a drug used to treat menopausal women with early breast cancer who have already been treated with tamoxifen, which is marketed by Pfizer (NYSE: PFE).
Afinitor, approved for use in kidney cancer patients in 2009, has also been approved to treat tumors in the brain and pancreas. Analysts say it could be Novartis’ next blockbuster drug, with projected sales topping more than $1 billion, seeing as it has already been approved for similar indications in Europe. Novartis’ U.S. headquarters are in East Hanover, New Jersey.
Afinitor is the first approval of an mTOR inhibitor drug against hormone-receptor positive advanced breast cancer, according to Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research in a statement from the regulator.
An mTOR inhibitor blocks the activity of of the mammalian target of rapamycin, which regulates growth factors that stimulate cell division and metabolism in tumor cells.
To date, more than six drugs have been approved to treat advanced breast cancer in post menopausal women.
A clinical study of 724 women designed to measure the length of time a patient lived without the cancer progressing, found that patients who received Afinitor plus Aromasin combination had a 4.6 month improvement in the median time to disease progression or death compared to patients receiving the placebo plus Aromasin, according to an FDA statement.
This year an estimated 226,870 women will be diagnosed with breast cancer, and about 39,510 will die from the disease, according to the FDA statement.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
