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By Charles Bankhead, Staff Writer, MedPage TodayThe FDA approved the immunotherapeutic agent sipuleucel-T (Provenge) for the treatment of advanced prostate cancer, almost three years after the agency rejected an advisory group's recommendation in favor of the drug.
The approval makes the agent available for treatment of men with asymptomatic or minimally symptomatic metastatic prostate cancer.
"The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available," Karen Midthun, MD, acting director of the FDA Center for Biologics Evaluation and Research, said in a statement.
Often described as a vaccine, sipuleucel-T is an autologous cellular immunotherapy designed to stimulate a patient's immune system to mount a response against prostate cancer.
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