FDA expands Pfizer drug approval for rare cancer
The Food and Drug Administration said Friday it expanded approval of a Pfizer drug to treat a rare form of pancreatic cancer.
The agency said it cleared Sutent to treat cancerous tumors of the pancreas that cannot be surgically removed, or have spread to other parts of the body. Such tumors are slow-growing and rare, affecting less than 1,000 U.S. patients each year, according to an FDA estimate.
Earlier this month the FDA approved Novartis' Afinitor for the same disease.
Sutent is a pill-based drug that blocks molecules involved in the growth and spread of tumors. It is already approved as a treatment for kidney cancer and for tumors of the stomach, esophagus, and bowels that do not respond to other treatment. The drug was first cleared by the FDA in 2006.
The FDA approved the drug based on a study of 171 patients in which those taking Sutent lived about five months longer without their disease spreading than patients taking a placebo.
Side effects with the drug include diarrhea, nausea, vomiting, fatigue, high blood pressure, energy loss, stomach pain and changes in hair color.