Paul Edwards Posted December 18, 2015 Share Posted December 18, 2015 At its November meeting the Pharmaceutical Advisory Committee (PBAC) considered an application to extend the listing of enzalutamide (brand name Xtandi) to include treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients who have not had prior docetaxel (chemotherapy). The PBAC has released its decision on the application. It is what the PBAC describes as a "1st time decision not to recommend". It's disappointing that the application was not successful but encouraging that the PBAC is asking Astellas to resubmit the application. Here is the full decision from the PBAC: "The PBAC decided not to recommend extending the PBS listing of enzalutamide to include treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients who have not had prior docetaxel because the submission was focused on a claim of survival advantage, which was small and uncertain, rather than on outcomes that clinicians and patients considered to be of most value. The purpose of using enzalutamide earlier in the disease pathway would be: 1) to delay symptoms from developing and maintaining a better quality of life for longer in asymptomatic patients for whom placebo, or watchful waiting, is the appropriate comparator; and2) delaying the toxicities of chemotherapy in symptomatic patients considered suitable for docetaxel. The PBAC noted the median time to initiation of cytotoxic chemotherapy in the PREVAIL trial was 28.0 months in the enzalutamide group versus 10.8 months in the placebo group, a median difference of 17.2 months, which was clinically meaningful. In contrast the overall survival gain of 4 months for enzalutamide in the same trial compared to enzalutamide in the post-docetaxel setting (4.8 months from the AFFIRM trial) highlighted the minimal impact of earlier enzalutamide treatment on overall survival. The PBAC therefore rejected the application because it did not appropriately reflect the value of early enzalutamide treatment. The PBAC encouraged a resubmission to evaluate the potential gains in quality of life based on the patient populations and outcomes described above". The Drug Company commented: "Astellas is disappointed not to have secured an extended PBS listing for patients with mCRPC who have not had prior docetaxel, but is grateful to the PBAC for their helpful feedback and advice." Link to comment Share on other sites More sharing options...
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