NICE has recommended that eligible men with metastatic hormone-sensitive prostate cancer (mHSPC) in England, Wales and Northern Ireland should have access to enzalutamide (Xtandi).

Enzalutamide is now the only oral therapy in the UK that has a licence to treat three distinct types of advanced prostate cancer - non-metastatic, and metastatic, castration-resistant prostate cancer (CRPC) and mHSPC.

mHSPC is an advanced form of prostate cancer, where the cancer has progressed (metastasised) outside of the prostate gland. The National Prostate Cancer Audit 2020 reported that up to 13% of men diagnosed with prostate cancer presented with metastases in the UK between April 2018 and March 2019.

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The Final Appraisal Determination is based on data from the pivotal Phase 3 ARCHES trial, which evaluated the safety and efficacy of enzalutamide in men with mHSPC. Data showed enzalutamide in combination with androgen deprivation therapy (ADT), significantly reduced the risk of metastatic progression or death by 61% versus placebo plus ADT in men with mHSPC.

Wider treatment options in the management of prostate cancer

Stephen Allen, Expert Patient Representative for Tackle Prostate Cancer, said: “We applaud this recommendation by NICE as it brings the prostate cancer community another option for mHSPC management. Despite huge progress in the field, there is still much to do but the recommendation signifies a step in the right direction for wider treatment options in the management of prostate cancer.”

The issue of improving the range of treatment options is particularly important in advanced prostate cancer, such as mHSPC. While the majority of men with prostate cancer will experience localised disease and a high rate of survival, men with metastatic prostate cancer tend to have a 30% overall five-year survival rate.

During the pandemic, the NHS provided interim special access to ‘Covid-friendly’ oncology treatments, including enzalutamide. 

Professor Heather Payne, Consultant Clinical Oncologist, University College London Hospitals NHS Trust, said: “Enzalutamide has played an important role in the UK during the Covid-19 pandemic, offering men with advanced forms of prostate cancer an alternative to hospital-based treatment, that could have left patients more susceptible to infection.

"As the NHS continues to navigate the challenges associated with the pandemic, it is welcome news that eligible patients can now have sustained access to this alternative oral treatment.”

Following the Final Appraisal Determination decision, guidance is due to be published by NICE in the near future.

For more articles on prostate cancer go to our oncology section