May 18, 2013 - 5:21 pm
Here’s the article:
Bayer's Xofigo for Prostate Cancer Gets Fast Approval
Its specific indication is for men with symptomatic, late-stage, castration-resistant prostate cancer with metastases in bone but not other organs, following conventional medical and/or surgical therapy to reduce testosterone levels.
The approval was based primarily on a placebo-controlled trial in 809 patients that showed a median overall survival time of 14 months in those receiving the drug compared with 11.2 months in the placebo group. Patients in the trial also received other treatments judged to be clinically appropriate on an individual basis.
Radium-223 dichloride binds chemically to minerals in bone "to deliver radiation directly to bone tumors, limiting the damage to surrounding tissues," said Richard Pazdur, MD, director of the FDA's Office of Hematology and Oncology Products, in a statement.
The approval, made through the agency's priority review process, came 3 months before the FDA's Aug. 14 deadline to render a decision.
Adverse effects seen with the drug in clinical trials included nausea, diarrhea, vomiting, and swelling of the leg, ankle, or foot, the FDA said. Hematologic effects included anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.