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.
STAMPEDE (NCT00268476) is a Cancer Research UK-funded study that is investigating multiple treatment combination treatments for prostate cancer. The therapies are given as an add-on to standard first-line hormone therapy and 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.
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. Most importantly, the committee said it couldn’t accurately estimate the drug’s cost-effectiveness based on the data submitted.
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.
“We understand that some men with prostate cancer will be disappointed by today’s news,” a NICE spokesperson told The Telegraph. “However, we can only recommend drugs that are clinically effective and show value for money compared to current treatment options. In this case, abiraterone has fallen short.”
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.
“We hope the manufacturer will be able to provide the data NICE needs as soon as possible so that the drug can be made available earlier in treatment,” said Paul Workman, chief executive of the ICR. “I’d also urge both parties to get together to discuss the price of abiraterone, as it is essential that those men who might benefit from earlier access to the drug do not miss out on the grounds of cost.”
“NICE should also revisit its decision within a year, as new trial data becomes available, rather than waiting three years as the committee report recommends,” Workman added.
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.
Zytiga’s active compound, abiraterone, was discovered at the ICR and developed in trials supported by its hospital partner, the Royal Marsden NHS Foundation Trust. The drug is considered a game-changer by the ICR for the treatment of prostate cancer.
Zytiga was recently celebrated as one of the greatest research achievements in the 70-year history of the NHS by the National Institute for Health Research.
Zytiga was also approved in the United States in February 2018 to treat metastatic high-risk castration-sensitive prostate cancer in combination with prednisone.
That same week, Health Canada also approved Zytiga in combination with prednisone and androgen deprivation therapy (ADT) to treat patients with newly diagnosed, high-risk metastatic hormone-sensitive prostate cancer (mHSPC), who may have previously received up to three months of ADT.