tonymax Posted February 11, 2014 Share Posted February 11, 2014 Radium 223 for the treatment of patients with symptomatic castrate resistant prostate cancer with skeletal metastases Assessment No 1268 Application Name Radium 223 for the treatment of patients with symptomatic castrate resistant prostate cancer with skeletal metastases Assessment Type Submission based assessment Description Of Medical Service Radium 223, which is an injection, is an alpha emitting pharmaceutical (alpha-pharmaceutical). This product naturally targets bone metastases due to its calcium-mimicking properties. The bone targeting property of radium-223 is similar to that of other earth alkaline elements, like strontium-89. However, the radiation characteristics of an alpha-particle emitting radionuclide seem to be more advantageous than a beta-emitting radionuclide. Radium-223, with a physical half-life of 11.4 days, emits high linear energy transfer alpha radiation, with a range limited to less than 100 micrometers, and can thus be used to generate localised radiation zones. An alpha-emitting radiation source located in a target tissue, such as skeletal metastases, will deliver the radiation to a more localised volume, thereby reducing exposure of surrounding normal tissues. Description Of Medical Condition Prostate cancer cell growth is stimulated by male hormones (androgens), in particular testosterone and its metabolite dihydro-testosterone. Therefore, patients may be treated by androgen deprivation to reduce levels of male hormones available to cancer cells. Androgen deprivation can be achieved surgically (castration), or medically using hormone therapy. Unfortunately, patients ultimately stop responding to hormone therapy and are then referred to as having hormone-refractory or androgen-independent prostate cancer. The most common site of cancer spread in men with hormone refractory prostate cancer is bone. Development of bone metastases is a major problem in prostate cancer and is a serious threat to a patient’s survival and quality of life. Untreated patients face severe morbidity, including bone pain, bone fracture, compression of the spinal cord and haematological consequences of bone marrow involvement. If treated successfully, these symptoms may be palliated and patients may also gain a survival benefit. Pre Assessment Meeting 7 December 2011 Stage 2 – Suitability for Assessment 11 January 2012 Proposed DAP Received 12 January 2012 Stage 3 - 1st PASC (Draft DAP considered) 12-13 April 2012 Stage 3 – Release for Public Comment (Consultation DAP) 28 May - 5 July 2012 Consultation Decision Analytic Protocol (DAP) - PDF Consultation Decision Analytic Protocol (DAP) - Accessible Word version Stage 3 - 2nd PASC (Final DAP) 16-17 August 2012 PDF version - Final Decision Analytic Protocol (updated) (PDF 1158 KB) Word version - Final Decision Analytic Protocol (updated) (Word 681 KB) Stage 4 - Submission of Collated Evidence To be advised by Applicant Stage 5 - ESC evaluation - Stage 6 - MSAC Appraisal - Stage 6 - MSAC advice - Stage 7 - Noting by Minister - Stage 8 - Implementation - Page currency, Latest update: 12 November, 2013 Alpharadin or Radium 223 was approved by the FDA (US Food and Drug Administration) on 15 May 2013 for the treatment of bone metastases of men with CRPC (Castration Resistant Prostate Cancer). The Trademark name of this new drug is Xofigo. The chart above shows just how far behind we can be in the approval process in this country compared to the USA. There are two links below where Dr Myers talks on the use of this new form of treatment. 28 January 2014 http://videos.videopress.com/Ei1J1O0A/xofigo-combinations-iphone_std.mp4 28 May 2013 http://videos.videopress.com/Y97VlU2J/alpharadin-computer_dvd.mp4 Link to comment Share on other sites More sharing options...
Paul Edwards Posted March 17, 2014 Share Posted March 17, 2014 An update on Tony's post: The Medical Services Advisory Committee is meeting next month (April 2014) to consider whether to approve Radium 223 Alpharadin (Brand name Xofigo) for use in Australia. Find out how to join in the campaign to get Xofigo approved in Australia. Link to comment Share on other sites More sharing options...
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