June 17th, 2013

FDA Approves Xofigo for Advanced Prostate Cancer


The U.S. Food and Drug Administration (FDA) has approved Xofigo® (radium Ra 223 dichloride) to treat men with metastatic, hormone-refractory prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.

Prostate cancer is a hormonally sensitive disease that can often be controlled for long periods with androgen-deprivation therapy (ADT). When prostate cancer stops responding to this treatment, it is referred to as hormone-refractory prostate cancer. Metastatic hormone-refractory prostate cancer is a challenging form of the disease to treat because the cancer has spread to distant sites in the body and does not respond to treatment with standard hormonal therapy.

Xofigo is a radiopharmaceutical agent that binds with minerals in the bone to deliver radiation directly to bone tumors, thereby limiting the damage to the surrounding normal tissues.

The approval was based on the results of a clinical trial that included 809 men with symptomatic hormone-refractory prostate cancer that had spread to bones, but not other organs. Patients were randomly assigned to receive Xofigoor a placebo plus standard treatment. The results indicated that men who received Xofigo lived a median of 14 months, compared to a median of 11.2 months for the ment in the placebo group. An updated analysis has confirmed that Xofigo can extend overall survival.

The most common side effects associated with Xofigo were nausea, diarrhea, vomiting and swelling of the leg, ankle or foot. The most common abnormalities detected during blood testing included low levels of red blood cells (anemia), lymphocytes (lymphocytopenia), white blood cells (leukopenia), platelets (thrombocytopenia) and infection-fighting white blood cells (neutropenia).

Xofigo was approved as part of the FDA’s priority review program, which allows an expedited six-month review of drugs that may offer major advances in treatment. The drug was approved more than three months ahead of the goal date.


FDA approves new drug for advanced prostate cancer. [FDA News Release]. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352363.htm

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Tags: Metastatic Stage IV (D) Prostate Cancer, News, Prostate Cancer, Refactory/Recurrent Prostate Cancer, Uncategorized