UK’s NICE Reverses Itself and Now Recommends Zytiga To Treat Men Before Chemotherapy

In a sudden reversal of its prior opinion the UK's National Institute for Health and Care Excellence (NICE) has issued final guidance recommending Janssen’s Zytiga (abiraterone) to treat advanced prostate cancer before chemotherapy. Its prior recommendation was not to approve Zytiga. TAccording to NICE their decision to change their December 2015 recommendation follows the submission of new evidence on the drug's benefits. At that time NICE indicated that the initial data submitted by Janssen failed to demonstrate quality of life and long-term survival. Since the denial Janssen has submitted extra data from a large group of men treated with Zytiga [...]

NICE Recommends Xtandi, but Not Zytiga in the Pre-Chemotherapy Stage of Advanced Prostate Cancer Treatment

NICE, which serves as a cost-effectiveness agency has said in a draft guidance that it supports the use of Xtandi (enzalutamide) in men whose prostate cancer has spread after the failure of first-line therapy (i.e. ADT), but for whom chemotherapy is not yet necessary. The agency found that Xtandi can delay the need for chemotherapy, is well tolerated, and improves survival.  After their review they have determined that Xtandi is an appropriate use of NHS resources, with an incremental cost-effectiveness ration of £34,500 compared to best supportive care. On the other hand NICE was less impressed with Johnson & Johnson's [...]

The Twists and Turns For Provenge

It was announced today that preliminary results from the Phase II STAND trial demonstrates continued and what is described as a robust immune response with Provenge (sipuleucel-T) that continues two years after completing treatment in men with biochemically-recurrent prostate cancer (BRPC). This finding, along with data from the ongoing Phase IV registry PROCEED trial, are being presented at the 2015 Genitourinary Cancers Symposium (ASCO GU) conference. The STAND study is a randomized, Phase II trial that consisted of two patient study groups designed to eventually allow the possible expansion of the FDA approval for Provenge to men who are still [...]

NICE Reverses Its Decision and Now Recommends Radium-223 (Xofigo) For Men Who Have Had Chemotherapy

According to Prostate Cancer UK The National Institute for Health and Care Excellence (NICE) has released its second draft decision on the availability of radium-223 (Xofigo). Different from the original draft this draft recommends that radium-223 be made available on the NHS for men with advanced prostate cancer that no longer responds to hormone therapy (castrate resistant prostate cancer) that has also spread to the bones. However, they only recommend it for these men if they've already been treated with chemotherapy. The Scottish Medicines Consortium (SMC), which operates independently of NICE, hasn’t yet considered radium-223 availability on the NHS in [...]

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