Archive for Alpharadin (radium-223)
Most people don’t know of the great work that has been carried out by group of determined advocates on behalf of men with advanced prostate cancer. These hard working advocates, who reach out across different advocacy groups (Malecare, PCRI , PHEN, PAACT and USTOO) have formed a committee they call the The Early/Expanded Access Committee (EAP).
The EAP meet with pharmaceutical companies on a regular basis to encourage them to make their promising drugs and treatments available to individuals before they have formally received FDA approval. They do this by the way of a vehicle they call the Early Access Program (EAP). The EAP identify drugs that are designed to treat men with advanced prostate cancer, that during their phase III trials clearly demonstrate great safety profiles and excellent efficacy, but have not yet received formal FDA approval.
As mentioned, the EAP meet with pharmaceutical company representatives to open the door for drug access, they help identify doctors who are willing to use these drugs, under the FDA guidance as a EAP clinical trial so that men don’t need to wait around for formal FDA approval. Not only does this program offer early access, it provides the pharmaceutical company and the FDA with a wealth of additional material about the safety and efficacy of the treatment which can be factored into their ultimate decision about approval.
THE EAP provides new hope for families around the world, they provide a paradigm that will be used in prostate and all other cancers in a short period of time.
The EAP has had three major successes to date, abiraterone, enzalutiamide and radium 223. Each of these drugs was made available to men in need prior to their receiving approval from the FDA, with the blessing of the FDA. The EAP recently performed an analysis of their impact with each of these drugs.
Jan Manarite (PCRI) who is an active member of the EAP, for the EAP “After the Expanded Access Committee had some success promoting and encouraging Expanded Access with our 3rd drug (radium 223), I always wanted to get the numbers, just to see what we did. Here’s what it looks like. I continue to think that small groups with simple goals can do big things….”
EAP Numbers – Patients Served
abiraterone *- 432 men received the treatment under the EAP from 33 states and the District of Columbia from Oct 2010 – Apr 2011
enzalutamide ** 508 men received the treatment under the EAP from 25 states and 6 Canadian Provinces from May 2012 – Aug 2012
radium 223*** 200 men received the treatment under the EAP from 18 states from Jan 2012 – May 2013
TOTAL MEN SERVED – 1140
* Joanne M. Vanak, RN, MSN, Senior Director, Scientific Advocacy, Janssen – 1/16/14
** Nahla Hasabou, MD, CCRP, Medical Monitor, Oncology Medical Science, Astellas – 9/3/13
*** Svetlana Babajanyan MS MD, Medical Director, Bayer HealthCare Pharmaceuticals Inc. – 8/5/13
This program is a roaring success fostered by the hard work from a number of different prostate cancer advocacy organizations as well as a number of dedicated physicians and researchers. One also needs to acknowledge the supportive role that the FDA has decided to take in encouraging these Early Access Trials.
Joel T. Nowak, M.A., M.S.W.
Men with metastatic castration-resistant prostate cancer (mCRPC) in Québec, Canada now have access to Zytiga (abiraterone acetate) prior to having chemotherapy.
Effective February 3, 2014, the province has added ZYTIGA to the public drug formulary for the treatment of mCRPC in men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT).
In July 2011, ZYTIGA was approved by Health Canada for the treatment of men with mCRPC who had received prior chemotherapy containing docetaxel after failure of ADT. Health Canada approved a second indication for ZYTIGA in May 2013 for the treatment of men with mCRPC who are asymptomatic or mildly symptomatic after failure of ADT.
Québec joins British Columbia as the second province to add ZYTIGA to its public formulary for men with mCRPC who are asymptomatic or mildly symptomatic after failure of ADT.
On the European front men with metastatic prostate cancer can now get radium-223 as it has now been approved by NHS England.
In April 2013 NHS took responsibility for cancer drugs and on February 2014,following a review of data by the chemotherapy clinical reference group, radium-233 (Xofigo) was added to their approved list.
In a statement, health secretary Jeremy Hunt said: “Better access to effective medicine is a priority for the Government, and we are delighted that these new drugs will mean more patients will join over 38,000 cancer sufferers who have already benefited from the fund.”
Prostate cancer drugs become increasingly available for men all over the world, but not at a rate that still sees many more men than necessary continue to suffer and die when there are proven drugs and treatments languish waiting for redundant reviews.
Perhaps our remarkable politicians and government administrators could go back to the thinking well and fix the system. Perhaps they should consider an interim automatic approvals for a drug once they have been approved somewhere else by one of their large and respected counterparts in the world. They could still perform their own review and come to their own conclusion, but while we wait these vital treatments will be available to their own citizens. This is a simple and safe approval system that should not threaten each county’s independence and speed the delivery of drugs to those in significant need.
Joel T. Nowak, M.A.S., M.A.
The first line of treatment for advanced prostate cancer is Androgen (male hormone) Deprivation Therapy or ADT. Once the PSA progresses (climbs) while still on ADT and with testosterone levels <20 ng/ml a man is said to be castrate resistant. At this juncture a man will need to continue on ADT while adding additional drugs to his therapy regimen.
The following is an alphabetical list of potential drugs that have been FDA approved (alphabetical because there is limited sequencing evidence available to determine the best order to take these treatments).
Jevtana® (cabazitaxel) used in combination with prednisone after the failure of docetaxel therapy (chemotherapy). Usually reserved to be used after Zytiga and Xtandi, but not required. Cabazitaxel is a semi-synthetic derivative of a natural taxoid, so it is related to docetaxel, but it still works after docetaxel failure.
Novantrone® (mitoxantrone) disrupts DNA synthesis and DNA repair in both healthy cells and cancer cells. It is usually held as a drug of last resort for men with prostate cancer as it does not convey any additional survival but it can provide palliative benefits.
Provenge® (sipuleucel-T) is an autologous cellular (made of your own cells) immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. The treatment sensitizes the immune system to prostate cancer cells. It is best used in an early disease state with a low PSA.
Taxotere® (Docetaxel “chemotherapy”) is an anti-mitotic treatment that interferes with cell division, especially fast growing cells. It encourages apoptosis, or programmed cell death.
Xofigo® (Radium-223 chloride) is an alpha emitting radio (short range radiation) pharmaceutical that seeks out bone metastases. It is used in men with symptomatic bone metastases and no known visceral metastatic disease.
Xtandi® (Enzalutamide aka MDV3100) is an androgen receptor antagonist drug, or a drug that blocks the cancer cells from absorbing and using the androgens that are being manufactured in the body. Approved only in the post-chemotherapy disease state. Sometimes, it is referred to as a “super” Casodex because of its similar, but souped up action.
Zytiga® (abiraterone) plus prednisone is used to treat men who have mCRPC. It is approved for both pre-chemotherapy and post-chemotherapy (docetaxel failure) disease states. It works by blocking the production of androgens from three sources; testicular, adrenal, and prostatic tumor tissues.
All the list drugs have the possibility of having many different and significant side effects. Before starting any of these drugs talk to your oncologist and learn about which side effects are serious and should be reported to the doctor or for which you should proceed to an emergency room for assistance. When in doubt, act – call the doctor or go to the emergency room.
Joel T. Nowak, M.A., M.S.W.