We are in the fortunate position because the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) continues to evolve as new agents with the ability to extend survival gain FDA approval. The most recently FDA approved treatment, the alpha emitting radiopharmaceutical radium-223 (Xofigo) was approved for men with bone metastatic prostate cancer.
Most other of the newly approved treatments was designed with the initial intention of providing an increase in overall survival (OS), but Xofigo is different. Like the other already approved radio emitting agents Strontium and Samarium which are beta-emitting agents Xofigo was initially explored solely as a palliative treatment option. However, the investigation quickly changed once it was discovered in very early trials that Xofigo, not like the other agents, also improved survival in addition to providing palliative benefit.
Besides a survival advantage, Xofigo also provides a great measure of superiority over the beta-emitting agents (which irradiate a large area including bone marrow) because as a alpha-emitting agent it only irradiates a very localized area. Since the vast majority of prostate cancer bone metastasis are in the bone and not in the marrow, Xofigo is very affective in treating these mets while not damaging the bone marrow, a significant advantage over the beta emitting treatments.
Xofigo is a game changer with a huge potential for a major role in our treatment protocol.
Joel T. Nowak, M.A., M.S.W.
I don’t believe that Radium-223 is yet approved in Holland. I am also not sure that he would be a candidate given that he has already absorbed large quantities of radiation from the Strontium. – Joel
I wonder how it is possible that my father, who just finished a treathment with strontium in St. Antoniusziekenhuis Sneek (Holland), and now is resistant for the strontium, can not get a Radium-223 (Alharadin) treathment in his hospital. Does anybody now how it’s possible that a treathment that is so positive wil not be given to him by his Oncologist dr. Veldhuis?
Regarding the usage of Ra-223 in Europe. OSLO, Norway, Sept. 20, 2013 (GLOBE NEWSWIRE) — Algeta ASA (OSE: ALGETA), announced today that Bayer has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending approval of Xofigo® (radium Ra 223 dichloride) in Europe. The proposed indication is for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. The decision of the European Commission (EC) on the approval is expected in the fourth quarter of 2013.
Joel, I am sure this was a typo in view of your extensive knowledge on this subject, but in your article, you mentioned:”Xofigo also provides a great measure of superiority over the alpha-emitting agents (which irradiate a large area including bone marrow) because it is a beta-emitting agent, which only irradiates a very localized area. ” It is actually the opposite since Ra-223 is the alpha emitter.
Thanks for the reply. Maybe thats the problem, but his specialist told him it was possible but now he doesnt take action. When is a medicine approved in Holland after its already approved in Europe.
I understood that Radium 223 can be taken 12 months after a strontium threatment. In some cases 6 months.
We keep asking for the treathment with Radium 223 because it’s the most usefull threatment at this moment. Maybe Rhenium 188 is the best threatment when Radium 223 wil not be approved at short time. But i don’t know enough about this medicine. For example can he use Radium 223 after the use of Rhenium 188 and other questions.
Joel, your third paragraph has it backward: Xofigo is an alpha emitter.
Xofigo is an Alpha emitter,which means it decays by emitting an Alpha particle while Strontium and Sammarium are Beta emitters. Alpha particles travel less than Betas and therefore are less harmful to bone marrow producing cells.
Thanks for picking up the error. I am changing it. – Joel
Harry – Look at Ghassan’s response as to when you might expect to have it approved in Holland. – Joel