FDA Approves Abraxane for Late-Stage Pancreatic Cancer
Previously sanctioned for cancers of the lung and breast
TUESDAY, Sept. 10 (HealthDay News) -- The U.S. Food and Drug Administration approval for Abraxane (paclitaxel) has been expanded to include advanced pancreatic cancer, the agency said Friday in a news release.
The agency previously approved the chemotherapy drug to treat cancers of the lung and breast.
Some 45,220 people are expected to be diagnosed with pancreatic cancer this year, and an estimated 38,460 will die from it, the FDA said.
Pancreatic cancer is the fourth-leading cause of cancer death. Surgery is the only way to permanently remove pancreatic cancer, but it's usually too late for surgery by the time most cases are identified, the agency said.
Abraxane's safety and effectiveness in treating pancreatic cancer were evaluated in clinical trials involving 861 people. Those treated with Abraxane and another chemotherapy drug, gemcitabine, lived an average of 1.8 months longer than those treated with gemcitabine alone.
Common side effects of the drug combination included a drop in white blood cells and blood platelets, fatigue, nerve damage in the extremities, vomiting, diarrhea, and fever.
Abraxane is marketed by Celgene, based in Summit, N.J.