Xgeva Will Hopefully be Quickly Approved in Japan
By · CommentsSome good news for men who are living in Japan and dealing with advanced prostate cancer. It was announced that Astellas and Medivation have submitted an application for marketing approval of Enzalutamide (Xtandi) in Japan.
Their application is based on results obtained from the global Phase 3 trial (the AFFIRM trial)* and a Phase 1-2 trial conducted in Japan. It was the AFFIRM trial that supplied the data that led to the FDA approval in the United States.
I can see no reason why the application shouldn’t be quickly approved in Japan.
Joel T Nowak, M.A., M.S.W.
The following is a post from Chuck Maack on the Advanced Prostate Cancer Internet support group:
“It came to mind wondering how many patients and/or their caregivers prescribed Zytiga/abiraterone acetate have ever taken the important time to read all the details regarding the effects that may be experienced by patients and whether or not they and their prescribing physician are insuring that appropriate blood testing is being performed at appropriat intervals to be aware of the numerous effects that can occur in order to remedy those effects in short order or even realize, depending on blood level results, should stop continuing with this medication. Please take that important time to read the lengthy information in this paper:
http://zytigahcp.com/prescribing-information.
If there are areas you don’t understand but appear important, write notes and take them with you to your next doctor appointment.
Zytiga is a remarkable medication for those who can tolerate the medication and whose blood levels remain within the defined appropriate levels. It provides at least a median of over 13 months effectiveness, and in my personal case has continued effectiveness for 20 months and continuing. “
As usual, Chuck is right on target. However, I want to add that this is true for all drugs we take, both drugs that treat advanced prostate cancer and drugs that treat a minor aliment.
Anything we put into our mouths, allow to be injected into our bodies comes with side effects, good ones and bad ones. Deciding to take a drug or treatment is always a decision which requires us to balance the positive possibilities against the negative possibilities.
We can only balance these by fully understanding what are the possible side effects that we might experience. When reviewing the information we also need to always keep in mind that the listed side effects are possible side effects. There is no way we have to predict what, if any, and to what extend we might experience a side effect, or even if the drug will work.
Become educated and make informed decisions. Do your homework and ask questions.
Thank you Chuck for thinking of us and pointing out this very important issue.
You can join the Advanced Prostate Cancer Internet Support Group by clicking on the below link:
http://health.groups.yahoo.com/group/advancedprostatecancer/join
Joel T Nowak, M.A., M.S.W.
Announcing A New Research Platform – Start A Cure
By · CommentsThe news is in, and it is bad. It is as bad as many of us feared. The National Institute of Health (NIH) has announced that their across-the-board budget sequester cuts are going to equal 1.71 billion dollars.
The NIH is responsible for the majority of cancer research performed in the United States. For the last number of years their budget has been shrinking and now we are faced with an additional loss of 1.71 billion dollars from the already diminished 2012 budget.
Each year we continue to struggle to just maintain funding for the Department of Defense Prostate Cancer Research Program (DOD PCRP). We used to have hopes of seeing an increase in what has been a flat $80,000,000 budget, now we celebrate the flat budget. Next year, the program may not even be around!
In light of this terrible situation and in consideration of a common complaint we hear at Malecare that people do not believe that the research that is being funded is often not what they want to see move ahead, we have launched a new program.
Our new program is called Start A Cure. We have reached out to a number of top-level researchers and asked them to submit to us prostate cancer research programs they are looking to fund. We have put together 17 proposals from institutions like The Johns Hopkins, Harvard and UCLA. Their projects all require less than $50,000 in funding.
We have put together a new funding platform where these projects can get funded despite the economic situation I described. We are asking that you go to www.startacure.com and read the researchers description of their research project. Find one two or even three projects that strike a chord with you and make a pledge to support the research. Your support can be for as little as $1.00 or as much as you can give.
It is time that we take some personal control of the research that is going to help us beat this beast, prostate cancer. Become a sponsor of break through research. Let the researchers know that we appreciate the work they do and their commitment to finding a cure for us.
Go to www.startacure.com and speak loudly. Join me in directing research that moves us closer to the cure for prostate cancer.
Joel T Nowak, M.A., M.S.W.
Ra 223 Dichloride (Xofigo®) Approved by the FDA
By · CommentsMore great news for men with advanced prostate cancer that is castrate resistant and who also have symptomatic bone metastases and no known visceral metastatic disease. Today, Bayer HealthCare announced that the U.S. Food and Drug Administration (FDA) has approved (radium Ra 223 dichloride).
Xofigo (zo-FEE-go) is the first and only alpha particle-emitting radioactive therapeutic agent approved by the FDA that has demonstrated improvement in overall survival (OS) and delay in time to first symptomatic skeletal event (SSE) compared to placebo, as shown in their pivotal Phase III ALSYMPCA trial.
Bayer says that the commercial production of Xofigo is underway, and first doses are expected to be ready for patient treatment within a few weeks. Bayer has worldwide exclusive marketing rights for Xofigo. It looks to me that my earlier statements about the prior slow down in product availability for the early access trials was correct. However, I can only hope now that the FDA has approved Xofigo® that the product will flow easily to men in need.
Oliver Sartor, MD, North American Principal Investigator for the pivotal trial and medical director of the Tulane Cancer Center said that “Xofigo has demonstrated an antitumor effect on bone metastases and will be an important addition to the treatment of this cancer.” I cannot agree more with him.
We know that bone is the most common site in the body to be affected by metastatic prostate cancer and that bone metastases are particularly prevalent. In reality, approximately 90% of men with metastatic prostate cancer show evidence of bone metastases. Bone metastases can lead to an increase in frequency of skeletal events and are shown to be the main cause of morbidity and death in men with CRPC.
The most common (greater than or equal to 10%) adverse side effects reported from the ALSYMPCA trial were nausea, diarrhea, vomiting and peripheral edema. The most common hematologic laboratory abnormalities (greater than or equal to 10%) were anemia, lymphocytopenia, leukopenia, thrombocytopenia and neutropenia.
Now we wait to see if Bayer is able to deliver the product.
Joel T Nowak, M.A., M.S.W.
