New Drug for Advanced Prostate Cancer Approved by FDA Due to Longer Survival Rate

Men battling with advanced prostate cancer can now live longer because of Xofigo.

Based on the data from the National Cancer Institute, approximately 238,590 men were recorded to have prostate cancer with a mortality rate of 13 percent. Prostate cancer is a disease that attacks the tissues of the prostate or the gland in the male reproductive system below the bladder and in front the rectum. It usually occurs to older men and is the sixth cause of cancer death in the world.

Algeta and Bayer, the drug manufacturers of Xofigo, were surprised that their product was approved now instead of the August 14, 2013 expected date. The FDA cautiously evaluated the drug and found out that it is safer and more effective compared to existing products in the market.

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said that "Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues. It 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."

809 men with advanced prostate cancer that have already spread to the bones but not to other organs tested Xofigo and had proven it safe and really effective. Not all the 809 participants were asked to use the drug to establish the difference of those who took it and those who did not.

The researchers aimed to quantify the survival rate of the participants. Those who took Xofigo lived in an average of 14 months while those who didn't lived 3 months shorter. A restructured and more investigative study was done later to further establish that it was really the drug that prolonged the life or the survival rate of the patients.