The US Food and Drug Administration has approved a new drug for the treatment of an advanced type of prostate cancer that spreads to the bones.
Xofigo, manufactured by Bayer Pharmaceuticals, will treat patients with metastatic castration-resistant prostate cancer that has spread to the bones, but not to other organs, after receiving medical or surgical therapy to lower testosterone.
The drug binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissue.
Bayer head of Global Development Kemal Malik explained; "Xofigo shows a favorable safety profile and has the potential to improve patient outcomes in a completely novel way. Radium 223 emits alpha particles that affect cancer cells in bone metastases and may contribute to a survival improvement."
"This FDA approval will provide prostate cancer patients and the physicians who care for them with a new and innovative treatment option."
The FDA said the drug was approved more than three months ahead of the product’s prescription drug user fee goal date under the agency’s priority review programme.
In August, a pivotal Phase III trial evaluated 809 men with CRPC and symptomatic bone metastases.
Results showed patients receiving Xofigo lived a median of 14 month,s compared to a median of 11.2 months for men receiving placebo.
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.
Image: Xofigo is approved for the treatment of metastatic castration-resistant prostate cancer that has spread to the bones. Photo: Courtesy of FreeDigitalPhotos.net.
