Just saw this article about
the FDA approving Zytiga for pre-chemo use.
Reuters (12/11, Berkrot, Pierson) reports that the US Food and Drug Administration on Monday announced that it has approved the expanded use of Johnson & Johnson's Zytiga (abiraterone acetate) to treat men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving chemotherapy. Initially, the FDA approved Zytiga, which decreases testosterone production, in April 2011 for use in patients whose prostate cancer progressed after treatment with the chemotherapy drug Taxotere (docetaxel).
The AP (12/11) adds that the agency "approved the new indication based on a J&J study of 1,088 men with late-stage prostate cancer who had not already received chemotherapy." The study participants who were administered Zytiga survived an average "five months longer" than the group given a placebo. Dr. Richard Pazdur, director of the FDA's Center for Drug Evaluation and Research, Office of Oncology Drug Products, said the agency's approval "provides patients and health care providers the option of using Zytiga earlier in the course of treatment." The most common side effects recorded during the clinical trials were "fatigue, joint swelling, diarrhea, vomiting, cough and shortness of breath."
Bloomberg News (12/11, Edney) reports that J&J's Development Team Leader Michael Meyers said that the new indication could expand the use of Zytiga "by as much as fourfold." Since it was approved in April 2011, Meyers said that about "20,000 men in the US have used the drug."
HealthDay (12/11, Preidt) and MedPage Today (12/11, Petrochko) also cover the expanded approval.