Bayer HealthCare has submitted a New Drug Application (NDA) to the US Food and Drug Administration for its investigational compound radium-223.
The drug has been demonstrated to help men with advanced prostate cancer live several (median of 3.6) months longer.
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Castration-resistant prostate cancer doesn’t respond well to therapies. Then, when advanced prostate cancer starts its deadly march, it spreads to the bone, as well as other organs. This can cause enormous pain, fractures and other complications that diminish quality of life.
This submission is based on the results of ALSYMPCA (ALpharadin in SYMptomaticProstate CAncer) trial, which involved 921 patients in more than 100 centers in 19 countries. The participants received either the radium-223 or a placebo and best standard of care.
The men who were treated received six intravenous injections of radium-223 or placebo. Each session was separated by four-week intervals.
Those who received the radium-223 lived a median of 14.9 months compared to 11.3 months for those receiving a placebo and standard care.
Most of the participants did have side effects – some serious - which included anemia, low white blood cell count, bone pain, nausea, diarrhea and vomiting. Bone pain was the most serious of the adverse events.
Bayer will be conducting other studies with this medication, including how it performs earlier in the disease process, as well as how it works with other agents. The company is even looking at its potential to treat breast and bone cancer.
Several days ago, the company also began the regulatory journey for approval of radium-223 in Europe.