Today, the US FDA approved Erleada (apalutamide), an androgen receptor inhibitor created by Janssen Pharmaceuticals for the treatment of men with non-metastatic, castration-resistant prostate cancer. Erleada was approved after a priority review of...
Radium-223 Dichloride, otherwise known as Xofigo, is the first alpha-emitting radiopharmaceutical used to treat prostate-cancer-related bone metastasis. The FDA approved Xofigo in May of 2013. The clinical trial that led to the FDA approval was called the ALSYMPCA trial. Eligible patients were randomized in a 2:1 fashion to either receive six monthly intravenous injections of radium-223 or best standard of care, such as antiandrogen hormonal therapy, local external beam radiation, corticosteroids, estramustine, or ketoconazole. The men who received radium-223 had improvement in bone pain and also experienced an increased survival.
Radium-223 is used to treat bone metastases, a common problem for men living with metastatic hormone resistant prostate cancer (MHRPC), affecting up to 90% of these patients. The development of a drug called radium-223 (brand name: Xofigo) is a substantial innovation, not only because it causes less toxicity compared to its predecessors, but also because it prolongs life.
In 2010, Provenge was approved by the FDA, the first approved prostate cancer treatment that functions by enhancing the immune system. Over the last couple ofyears Provenge has been gaining popularity with oncologists and urologists as well as with patients. What has been surprising to me is how slowly doctors and patients have warmed up to the idea of using the immune system to fight prostate cancer. For years my patients have been taking handfuls of Graviola, Shitaki mushrooms, Pau de Arco and Esiac tea because of unsubstantiated claims of immune enhancement. Yet, when the FDA approved an effective immune treatment that prolongs life I was surprised that my patients needed to be convinced to use it.
Radium-223 (or Alpharadin) is a new targeted alpha-emitting agent which has shown a prolongation of survival in castrate-resistant prostate cancer patients with bone-metastatic disease (5).
Every day in the office, as a practicing prostate oncologist, I confront serious problems: PSA levels that are rising, treatments causing too many side effects, patients desperately worried about their future. And sometimes, given our limited tools, the solutions we can offer are only partial. However, every time the FDA approves a new treatment there is an excitement akin to opening gifts on Christmas morning. All of a sudden we have a shiny new tool in the tool chest to help us do a better job.
I have never seen a real game of chicken where two cars race head on toward each other to see who will swerve first, i.e., who is chicken. However, we are seeing an actual game of chicken being played out before our eyes on the national stage.
One of the unique characteristics of prostate cancer is its responsiveness to the withdrawal of testosterone. This “Achilles Heel” of prostate cancer was discovered in the 1940’s when surgical removal of the testicles was shown to induce cancer remissions. In 1985, Lupron, an injectable medication that works by tricking the testicles into ceasing testosterone production, was FDA approved. Orchiectomy, or surgical removal of the testicles, has been declining in popularity ever since.
Using the immune system to fight cancer is a rapidly advancing area of research. The immune system (as it relates to fighting cancer) is made up of three components: 1) regulatory cells (TRegs), 2) killer cells, and 3) detector cells otherwise known as dendritic cells. Dendritic cells activate the killer cells and help them “home in” on the cancer.