Health trends

Metastatic colorectal cancer drug approved

The US Food and Drug Administration recently approved Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with colorectal cancer.

Zaltrap is an angiogenesis inhibitor that inhibits the blood supply to tumours.

It is intended for patients whose cancer has spread to other parts of the body (metastatic) and whose tumours are resistant to or progressed after an oxaliplatin-containing chemotherapy regimen. Colorectal cancer is the fourth most commonly diagnosed cancer and the fourth leading cause of cancer death in the United States. According to the National Institutes for Health, an estimated 143,460 Americans will be diagnosed with colorectal cancer and 51,690 will die from the disease in 2012.

"This approval demonstrates the benefits of adding a biological agent, Zaltrap, to a commonly used chemotherapy drug regimen, FOLFIRI," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "An improvement in median survival time was noted with the addition of Zaltrap to FOLFIRI, accompanied by an improvement in response rate and a delay in tumour progression and growth."

- Source: The US Food and Drug Administration

Lucentis approved for diabetes eye disease

The US Food and Drug Administration last week approved Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (DME), a sight-threatening eye disease that occurs in people with diabetes. An injection administered once a month by a health care professional, Lucentis is intended to be used along with good diabetic blood sugar control.

DME is a condition in which fluid leaks into the macula, the centre part of the retina where sharp, straight-forward vision occurs. The fluid makes the macula swell, causing vision to blur. According to the Centers for Disease Control and Prevention, diabetes (type 1 and type 2) affects about 26 million people in the United States and is the leading cause of new blindness among people ages 20 to 74 years. In 2010, 3.9 million adults diagnosed with diabetes reported trouble with their vision.

"Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema," said Renata Albrecht, MD, director of the Division of Transplant and Ophthalmology Products in FDA's Center for Drug Evaluation and Research. "Today's approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease."

The FDA previously had approved Lucentis to treat wet (neovascular) age-related macular degeneration, a condition in which abnormal blood vessels grow and leak fluid into the macula. Lucentis also is approved to treat macular edema following retinal vein occlusion, a blockage of the small veins that carry blood away from the retina that can cause fluid to leak into the macula.

- Source: The US Food and Drug Administration