"The U.S. Food and Drug Administration said it will fast track [this drug], and I don't think additional data will be required," study lead author Dr. Oliver Sartor, professor of cancer research at the Tulane University School of Medicine in New Orleans, said at a meeting press briefing. He said the hope is that this drug will be available to patients in 2012. Ra-223 is being developed by Algeta ASA and Bayer Healthcare. The study was funded by Algeta ASA.
In a second trial, another experimental medicine, called MDV3100, appeared to boost survival by close to five months among men with advanced prostate cancer. This drug works by preventing male sex hormones (such as testosterone) from binding to receptors on cancer cells (the tumor needs these hormones to survive and thrive).
In the study, close to 1,200 men received either MDV3100 or an inactive placebo. Median overall survival was 18.4 months for men treated with the experimental drug compared with 13.6 months for those receiving placebo.
The new drug also reduced the risk of death by 37 percent compared to placebo, the researchers said.
Side effects included fatigue, diarrhea and hot flushes, and were generally considered mild, lead author Dr. Howard Scher, chief of the genitourinary oncology service and chair of Urologic Oncology at Memorial Sloan-Kettering Cancer Center in New York City, said at the press briefing. This drug is being developed by Medivation and Astellas Pharma. The study was funded by Medivation.
"This is very impressive and unprecedented," added Dr. Nicholas Vogelzang, chair and medical director of the developmental therapeutics committee of U.S. Oncology, a research network specializing in cancer clinical trials. He moderated the press conference announcing the new study results. "This is going to change the way we take care of
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