Tuesday 16 April 2013

Prostate Cancer: Not much hope for new drug but ...




Prostate Cancer: Not much hope yet for new drug but …

 

01May13: There is not much hope yet for Australian men with incurable prostate cancer who need Abiraterone unless they are rich and chemotherapy is not working

 

The approval process for the new drug, also called Zytiga, appears to have stalled. There is no positive news, just one small ray of hope for the future.

 

I am reliably informed that the manufacturer, Janssen-Cilag is currently working with the TGA to have Abiraterone registered for the treatment of mCRPC patients who have not received chemotherapy (as is now the case in the USA) and intends to seek PBS subsidy for this indication. Unfortunately, this process can seem interminable.

 

This has to succeed to save Australian patients from a premature painful death.

 

All who have not yet signed the petition to the Minister for Health, Tanya Plibersek, are urgently invited to do so at: http://chn.ge/QsuSHc . Read more below.
 

 



 

Government Inaction on New Prostate Cancer Drug Abiraterone (Zytiga) Gets Media Attention

 

In “The International News Magazine” on Thursday, 28 March 2013 Greg Rogers published and article,  “Prostate Cancer Treatment Zytiga Needs Listing on the Pharmaceutical Benefits Scheme”  (URL for article: http://goo.gl/saNM9  ).

 

Greg also provided the following link to a letter from The PCFA (Prostate Cancer Foundation of Australia) to the Minister urging immediate action. Read that letter here.

 

This issue was also explored by Rachael Brown on 31 March 2013 in an article in the Sydney Morning Herald, "Prostate cancer drug tied up in red tape" (See: http://goo.gl/hEgFl ).

 

You can help change the discrimination against many incurable prostate cancer patients in Australia by signing the petition to the Minister for Health, "PBS should pay for Abiraterone for all incurable prostate cancer patients" and broadcast this request to all your contacts asking them to sign this petition (see URL:  http://chn.ge/QsuSHc ). All such help is much appreciated.

 

Here is a bit of further clarification. Only half the story is getting publicity. Even when the government eventually approves PBS listing there are many more incurable mCRPC patients who are not be eligible and so they are going to die painfully sooner than they should.

 

This is happening in Australia because the PBAC recommendation for a PBS subsidy for this drug is only for those patients who have failed a course of chemotherapy and are on their last legs. For this (first) group to get the drug the Federal Minister now only needs to give approval. So far she hasn't and the process is dragging on while patients suffer and die.

 

In USA the FDA has now approved Abiraterone acetate (Zytiga) for a second group of men with advanced prostate cancer without demanding they first fail a course of chemotherapy to qualify.

 

In Australia, because of the huge cost of Abiraterone and a lack of anyone seeking a PBS subsidy, those in this second group of incurables are doomed to suffer the ongoing ravages of their cancer and the side effects of chemotherapy until they also are "death's door". Only then, with little time left, may they hope to join the first group.

 

At present there is no such recommendation even being considered for pre-chemotherapy patients – seemingly not even from the manufacturer; not from the medical profession; not from involved community organizations. Several thousand incurables who could have a useful and pain free extension of life "pre-chemo" are being denied this effective treatment and an earlier death is guaranteed by the inaction. Please sign and get your friends to sign this petition at:  http://chn.ge/QsuSHc , and what about an email to your local member and the Leader of the Opposition  tony.abbott.mp@aph.gov.au .

 

References and supporting articles:

In the New England Journal of Medicine (NEJM) on 17 January, 2013 researchers concluded that, "Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy" improved radiographic progression-free survival, showed a trend toward improved overall survival, and significantly delayed clinical decline and initiation of chemotherapy in patients with metastatic castration-resistant prostate cancer." (see URL:  http://www.nejm.org/doi/full/10.1056/NEJMoa1209096 )

 

A review in UroToday (Urology News) published on 08 February 2013 interprets the (NEJM) report above as, "this shows that the patients can live longer without disease progression, can live longer without symptoms, can live longer until performance status deteriorates, can live longer until receiving chemotherapy, can live longer until starting opiates for pain, and probably live longer overall."  (see URL:   http://goo.gl/D2NGm )