JimJimJimJim Posted August 23, 2014 Share Posted August 23, 2014 Jim Marshall (not a doctor) said ... The Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that Xtandi (enzalutamide) be approved for use in metastatic castrate resistant prostate cancer after chemotherapy with Taxotere (docetaxel). Next step in the approval process is for the federal Cabinet to approve the money. Wish us luck. I would like to thank the Committee members who helped write a submission Xtandi this to the PBAC at the last minute. I think every little helps. Our committee: Nev Black, Paul Hobson, Alan Barlee, Tony Maxwell and yours truly, Jim Marshall ... end Jim Outcome of the meeting:=============================ENZALUTAMIDE, capsule, 40 mg Xtandi® Astellas Pharma Australia Pty Ltd New listing (Major submission)=============================Prostate cancer=============================Authority required (Streamlined) listing for the treatment of patients with metastatic castration resistant prostate cancer who have previously received docetaxel and who meet certain criteria.=============================The PBAC recommended an Authority required listing for enzalutamide for the treatment of metastatic prostate cancer after treatment failure with docetaxel, on a cost-minimisation basis with abiraterone. The equi-effective doses are enzalutamide 160 mg and abiraterone 1000 mg. On the basis of indirect evidence presented by the submission, the comparison of enzalutamide and abiraterone suggested a similar benefit in overall survival. On the basis of indirect evidence presented by the submission, enzalutamide is well tolerated and appears to have a similar safety profile to abiraterone, but does not require monitoring of liver function and blood pressure, which is required with abiraterone.============================= Link to comment Share on other sites More sharing options...
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