Comment 34 of 64, added on May 25th, 2013 at 1:43 PM.
Venturi, US Open champion and CBS analyst, dies
The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223
dichloride) to treat men with symptomatic late-stage (metastatic)
castration-resistant 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 forms in a gland in the male reproductive system found
below the bladder and in front of the rectum. The male sex hormone
testosterone stimulates the prostate tumors to grow. According to the
National Cancer Institute, an estimated 238,590 men will be diagnosed with
prostate cancer and 29,720 will die from the disease in 2013.
Xofigo is being approved more than three months ahead of the product¡¯s
prescription drug user fee goal date of Aug. 14, 2013, the date the agency
was scheduled to complete review of the drug application. The FDA reviewed
Xofigo under the agency¡¯s priority review program, which provides for an
expedited review of drugs that appear to provide safe and effective therapy
when no satisfactory alternative therapy exists, or offer significant
improvement compared to marketed products.
¡°Xofigo binds with minerals in the bone to deliver radiation directly to
bone tumors, limiting the damage to the surrounding normal tissues,¡± said
Richard Pazdur, M.D., director of the Office of Hematology and Oncology
Products in the FDA¡¯s Center for Drug Evaluation and Research. ¡°Xofigo is
the second prostate cancer drug approved by the FDA in the past year that
demonstrates an ability to extend the survival of men with metastatic
In August 2012, the FDA approved Xtandi to treat men with metastatic
castration-resistant prostate cancer that has spread or recurred, even with
medical or surgical therapy to minimize testosterone. Xtandi is approved
for patients who have previously been treated the chemotherapy drug
Xofigo¡¯s safety and effectiveness were evaluated in a single clinical
trial of 809 men with symptomatic castration-resistant prostate cancer that
spread to bones but not to other organs. Patients were randomly assigned to
receive Xofigo or a placebo plus best standard of care.
The study was designed to measure overall survival. Results from a
pre-planned interim analysis showed men receiving Xofigo lived a median of
14 months compared to a median of 11.2 months for men receiving placebo. An
exploratory updated analysis conducted later in the trial confirmed
Xofigo¡¯s ability to extend overall survival.
The most common side effects reported during clinical trials in men
receiving 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).