The USFDA has approved Xofigo (radium Ra 223 dichloride) for the treatment of advanced prostate cancer three months ahead of schedule under the priority review programme.
The approval allows Xofigo to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones, but not to other organs, after receiving medical or surgical therapy to lower testosterone.
FDA center for drug evaluation and research, office of haematology and oncology products director Dr Richard Pazdur said the damage to the surrounding normal tissues is limited as Xofigo binds with minerals in the bone to deliver radiation directly to bone tumours.
"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 prostate cancer," Pazdur said.
The safety and efficacy of Xofigo was assessed in a single trial of 809 men with symptomatic castration-resistant prostate cancer, who were randomised with Xofigo or a placebo plus best standard of care.
Pre-planned interim analysis indicated that men receiving Xofigo lived a median of 14 months compared to a median of 11.2 months for men receiving placebo.
Xofigo's ability to extend overall survival was confirmed in an exploratory updated analysis conducted later in the trial.
The most common side-effects noted were nausea, diarrhoea, vomiting and swelling of the leg, ankle or foot.
Low levels of red blood cells (anaemia), lymphocytes (lymphocytopenia), white blood cells (leukopenia), platelets (thrombocytopenia) and infection-fighting white blood cells (neutropenia) were the most common abnormalities detected during blood testing.
In August 2012, the FDA approved the drug Xtandi, which was developed to treat men with metastatic castration-resistant prostate cancer that has spread or recurred, after medical or surgical therapy.
Bayer Pharmaceuticals will market Xofigo while Astellas Pharma and Medivation are co-marketing Xtandi.