Zytiga Rejected in England as First Line Treatment for Advanced Prostate Cancer

The following is bad news for men in England with advanced prostate cancer. The rationale behind making this drug unavailable to men was cost. If anyone here in the US recommends we switch to the British system of health care, this should serve as a wakeup call against it. The therapy as described in the link below has been approved in the USA on the basis of two major clinical trials.

Janssen’s medication Zytiga (abiraterone) was recently rejected as a first-line treatment for newly diagnosed advanced prostate cancer on the National Health Service (NHS) in England following an initial draft recommendation from the National Institute for Health and Care Excellence (NICE). The negative recommendation means Zytiga won’t be made routinely available for men with newly diagnosed metastatic prostate cancer. As it is recommended now, Zytiga will only be prescribed through the NHS for these men once standard hormone treatment or chemotherapy has failed.

In two recent Phase 3 trials – STAMPEDE and LATITUDE – first-line therapy with Zytiga along with steroids and hormone therapy was found to  reduce the chance of cancer recurrence and improve survival, compared to hormone therapy alone. Patients were all at high risk of their disease spreading, and treated earlier, before their disease become resistant to standard hormone therapy. After three years, 83 percent of patients taking Zytiga, prednisolone, and hormone therapy remained alive, compared to 76 percent in the control arm. Also, the combination reduced the risk of disease worsening or death by 71 percent.

LATITUDE  included men with prostate cancer whose cancer had already spread at the time of diagnosis but who had yet to receive hormone treatment. The LATITUDE trial compared patients treated with standard hormone therapy to those treated with hormone therapy plus Zytiga and the steroid prednisone. The combination reduced the risk of death by 38 percent.

“Two clinical trials published last year provided compelling evidence of the huge potential benefit of abiraterone [Zytiga] for these patients,” Sir Harpal Kumar, chief executive of Cancer Research UK, said in a press release, expressing his disappointment.

NICE highlights its key reasons for not recommending the therapy because it couldn’t accurately estimate the drug’s cost-effectiveness based on the data submitted.  NICE concluded they could only recommend drugs that are clinically effective and show value for money compared to current treatment options. In this case, abiraterone has fallen short.  Janssen can now submit additional data to help NICE resolve these questions and review the revised data later this summer, before a final decision is made.

Following this draft recommendation, the Institute of Cancer Research (ICR) also expressed disappointment that Zytiga will not be made available to these patients as a first-line treatment, at least for now. The ICR is now calling for urgent discussions about the data supporting the drug’s effectiveness earlier in treatment as well as the drug’s price.

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