The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending that people with hormone-relapsed prostate cancer that has spread to other parts of the body and have been treated with docetaxel should be given access to Astellas Pharma’s Xtandi (enzalutamide).

In previous draft recommendations, NICE had not recommended use of Xtandi in people who had previously been treated with Johnson & Johnson’s Zytiga (abiraterone), but following the response to a consultation, this has been removed from the guidance recommendations.

As part of the consultation, Astellas had provided NICE’s independent appraisal committee with some new observations studies looking at how well Xtandi worked in patients who had received previous treatment with Zytiga, which showed that a proportion of these patients may benefit from such treatment. However, the committee felt there were too many uncertainties in the evidence for them to be able determine the clinical and cost-effectiveness of using Xtandi following treatment with Zytiga, and this view was supported by both the manufacturer and professional organisations responding to the consultation. 

Therefore, the panel concluded that it was not possible at this stage to make a recommendation on the clinical and cost-effectiveness of Xtandi when given after Zytigo; consequently, the use of Xtandi in this context is no longer covered by this guidance.

Commenting on the final draft guidance, Professor Carole Longson, director of NICE’s health technology evaluation centre, noted that Xtandi “is a new drug that works in a different way to the others currently available for treating prostate cancer, and as there are few treatments available for patients at this stage of prostate cancer, we are very pleased to be able to recommend it.”

“We know the manufacturer is currently collecting data on the use of enzalutamide after abiraterone and we look forward to seeing the results of the ongoing trials,” she added.

The decision has been welcomed by Dr Alan McDougall, medical director at Astellas Pharma Ltd, who said: “we believe that all appropriate patients who can benefit should have access to enzalutamide on the NHS, which will allow clinicians to make the best treatment decisions for their patients.”

Dr Heather Payne, consultant in clinical oncology at University College Hospital, added that she was “delighted” with the decision, which she said is “great news for clinicians and will benefit many patients.”

“Enzalutamide represents an important breakthrough in the management of this disease and has demonstrated survival benefit whilst offering patients improved quality of life,” said Dr Payne.