New NICE recommendation for Astellas prostate cancer drug

pharmafile | June 8, 2021 | News story | Manufacturing and Production Astellas, NICE, prostate cancer 

A newly published Final Appraisal Determination by NICE has recommended Astellas’ Xtandi (enzalutamide) plus androgen deprivation therapy (ADT), as an option for treating hormone-sensitive metastatic prostate cancer (mHSPC) in adults.

An estimated 8,500 men with mHSPC in England, Wales, and Northern Ireland will now have access to the androgen receptor inhibitor, the only oral therapy in the UK that has a licence to treat three distinct types of advanced prostate cancer.

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.

Enzalutamide works by blocking the effect of the hormone testosterone on prostate cancer cells. Without testosterone, the prostate cancer cells can’t grow, even if they have spread to other parts of the body.

Dr Tim Patel, Medical Director at Astellas UK and Ireland, said: “Every 45 minutes one man dies from prostate cancer in the UK, resulting in more than 11,500 deaths a year. The prevalence of advanced prostate cancer in the UK underlines the need for additional treatment options so that they can be tailored to suit individual patients.

“The NICE recommendation of enzalutamide promises another option to men with mHSPC, who face a poor prognosis, with hopes of providing them with another effective treatment choice.”

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, that included 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.”

The approval of Xtandi is based upon the Phase III Arches trial, a double-blind, placebo-controlled study that enrolled 1,150 patients with mHSPC at sites in the US, Canada, Europe, South America, and the Asia-Pacific region. Data showed enzalutamide in combination with ADT, significantly reduced the risk of metastatic progression or death by 61% versus placebo plus ADT in men with mHSPC.

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.”

Kat Jenkins

Related Content

AstraZeneca and MSD’s Lynparza receives NICE positive recommendation as a cancer maintenance treatment

UK-based pharmaceutical company AstraZeneca has announced that the National Institute for Health and Care Excellence …

NICE approves first treatment for obstructive HCM for NHS use

The National Institute for Health and Care Excellence (NICE) has announced that it has approved …

NICE recommends Pfizer’s rimegepant for preventing episodic migraine attacks

The National Institute for Health and Care Excellence (NICE) has announced that it has recommended …

Latest content