Archive for Alpharadin (radium-223)
A few weeks during a devistating manufactoring problem and eventual shut down of all production many men who were relying on Xofigo (radium-233 dichloride) were put into the untenable position of missing their scheduled doses. There was mass confusion about what to do in this circumstance. Men and their doctors didn’t know if they should just continue to wait for the problem’s resolution or to move on to a different drug. When the problem was resolved there was no evidence based information that could guide men if they should just start taking their Xofigo where they left off or perhaps attempt to start the protocol again from the beginning.
In reality we will never know what was the best course nor what the actual result of the shortage of the drug wil be for the men who missed their treatment.
Yesterday there was a joint media release from Bayer HealthCare and Cardinal Healthcare announcing that thet have entered into an agreement which will have Cardinal build a new 64,000 square foot plant in Indianapolis to manufactor Xofigo. The plan calls for the product made by this plant to be distrbuted in both the United States and in Canada. The plant s scheduled to come on line in 2017.
At the time of the crisis Malecare was told that there were plans to build a new plant in the United States. This announcment clearly fufills this promise, but it still falls short as a perfect solution to another large plant shutdown.
The current plant in Norway will continue to manufactor Xofigo, but as the drug continues to grab market share it would not be capable of picking up the slack if there is another shut down.
We applaud Bayer HealthCare and their affirmative action. But, we also ask them to consider building another, third plant that might be able to step into a problem and mediate the affects of one plant being closed. Putting all your eggs into one basket isn’t always the best solution.
See the press release: http://ir.cardinalhealth.com/m/#/Press_Releases/b1986ef2-849c-4297-9123-e2ce10a75f05
Officials from the National Institute for Health and Care Excellence (Nice) have made a preliminary decision not to recommend covering the drug radium-223 dichloride (Xofigo) for use for men with prostate cancer that has spread to the bone.
This latest draft guidance from Nice states that Bayer has not provided information on how Xofigo performs in contrast to other currently available drugs for use in the health service in England and Wales.
Malecare is urging that Bayer provide the required information prior to NICE making their final determination so that men in need will not be denied this safe and effective drug. We know that Xofigo can extend survival by 3.6 months and improve the quality of life with only minor side effects.
Men qualifying for Xofigo are already have very progressed disease with multiple bone metastases. It is nothing short of criminal that they be denied this proven treatment, especially when they are in a position where there are so little alternatives and often suffering with significant pain.
According to Nice chief executive Sir Andrew Dillon: “Clinical specialists told the committee that radium-223 (Xofigo) would be used as an alternative treatment option to docetaxel as an initial treatment, and abiraterone as a second-line treatment when the disease has progressed. However, Bayer did not to provide the committee with any data on how well radium-223 works compared to docetaxel or abiraterone or, only comparing it to a placebo.” I find this confusing, as Xofigo should not be used as an alternative to docetaxel or abiraterone, but as an additional treatment.
Joel T Nowak, M.A., M.S.W.
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.