FDA Approves Afinitor for Advanced Breast Cancer

The US Food and Drug Administration (FDA) has approved Afinitor in advanced breast cancer treatment. The medicine is only for postmenopausal women battling an advanced form of estrogen-sensitive tumor known as hormone-receptor positive, HER2-negative breast cancer. The pill-based drug is being used to treat various tumors of the pancreas, kidney and brain.

 "Afinitor is the first and only treatment that boosts the effectiveness of endocrine therapy, significantly extending the time woman with advanced breast cancer lives without tumor progression," said Gabriel Hortobagyi, MD, Chair of Breast Medical Oncology, University of Texas MD Anderson Cancer Centre. "This approval redefines the treatment and management of advanced hormone receptor-positive breast cancer, offering a critical new option for physicians and patients."

It is estimated that every year nearly 220,000 women globally will be diagnosed with advanced HR+ breast cancer, the most common form of the disease. In the U.S alone nearly 40,000 people are expected to be newly diagnosed with advanced breast cancer this year alone. Approximately 70 percent of all invasive breast cancers are positive for HR expression at the time of diagnosis.

FDA approval of this drug was based on a clinical trial that involved 724 postmenopausal women with advanced breast cancer that had increased despite taking sufficient treatment with Femera and Arimidex.

During the trail the women also consumed the standard breast cancer drug Aromasin. The researchers noticed that Afinitor boosted average progression-free survival (the time the women lived without any progression of their tumor) by 4.6 months compared to women taking an inactive placebo.

The aim of this study was to check the duration the patient lived without cancer multiplying.

The most common side effects of Afinitor observed in patients is mouth ulcers, infections, rash, fatigue, diarrhoea, and decreased appetite.

Prior to this Afinitor had won the approval of FDA to treat patients with advanced renal cell carcinoma, in adult patients with progressive advanced neuroendocrine tumors of pancreatic origin, for patients with renal angiomyolipoma and tuberous sclerosis complex (TSC) not requiring immediate surgery, and for adults and children with subependymal giant cell astrocytoma associated with TSC who require treatment but are not candidates for curative surgery.

Dr. Stephanie Bernik, chief of surgical oncology at Lenox Hill Hospital in New York City, concluded saying,  "It is exciting that there continues to be advances in treating breast cancer that are allowing patients to survive longer, even in the face of metastatic disease. The improved treatment for advanced-stage breast cancer offers women hope that a treatment to completely stabilize, or even eradicate the disease, might be achievable within their lifetime."