New Bone-Building Drug for Prostate Cancer Patients
According to a researchers report, a new drug for building bones has been found successful in a test conducted for men who had undergone a hormone therapy used for curing prostate cancer, as a result of which their bones had been weakened.
Amgen Inc. believes that denosumab (Prolia), the drug, which is a monoclonal anti-body, can be marketed for prevention of fractures not only in the men who have prostate cancer but also for the post-menopausal ladies who are undergoing hormone therapy procedure for the treatment of their breast cancer. An advisory panel from the US FDA has been scheduled for a meeting very soon to consider upon the application made by Amegen.
The author of the study, Dr. Matthew R. Smith, the director of genitourinary medical oncology at the Massachusetts General Hospital said that 2 million men in America receive the hormone blocking therapy for treating prostate cancer and from one third to around one half of them are potentially using Denosumab.
Denosumab works by blocking the activities of the molecule which causes destruction of the bone cells. Due to the lack of hormones, both men and women lose bones. Patients are given intravenous injection of this drug once in every 6 months.
Smith said that this study is an important one because there has no large scale study for men before which deals in preventing fractures. Over 900 men were enrolled in the study who were already receiving treatment at 156 different medical centers of US and Europe.
It was found that over a period of 2 years, the density of bones increased by 5.6% in men who received denosumab and decreased by 1% in men who were received a placebo. Over 3 years, incidences of fractures of the spine was 1.5% among people who received denosumab while 3.9% in those who received placebo.
Dr. Sundeep Khosla, a medicinal professor in Endocrine Research Unit of Mayo Clinic, wrote a supplementary editorial in which he mentioned that although denosumab is a significant drug and largely effects the condition in both the studies published, it is yet to be decided whether it can be used in prostate cancer therapy or not.
Khosla said that several other drugs are now being in use for preventing bone fractures in men who have received treatment for prostate cancer. Because all other drugs seem to have a similar sort of efficiency, the position of this drug is yet to be decided.
Khosla said that zoledronic acid (Zometa) seems to give tough competition to Denosumab. Zometa is a new member in the family of bone-building bisphosphonate. It is also given intravenously, requiring only one injection in the whole year. But the main difference and point of consideration is that zoledronic acid has to be taken under professional guidance of a physician only while Denosumab can be taken under self-administration.
Cost also seems to be a major issue for use of these drugs. A generic bisphosphonate may be available at as low as only $100 in a year while zoledronic acid comes at the wholesale rate of $1300 per year. Khosla said we still do not know how much Amgen will set the cost for the drug. But whatever will be the price, it will be a great thing for some groups of patients. Khosla also agrees with the statement from Smith that around one third to one half of men who receive hormone blocking therapy will be in these groups.
There are some concerns that denosumab can have some effects over the immune system of the person because the molecule that is blocked by it plays a significant role in a human body’s immune response. A study conducted on the post-menopausal women showed some problems related to the immunity such as increase in eczema incidences. Khosla said that although there have been concerns; they are not significant enough to disapprove the medication, although a surveillance may be needed.