Darolutamide + ADT in combination with docetaxel, for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC), is available immediately in England for eligible patients, following marketing authorisation from the MHRA and through a first-in-Europe early access agreement with NHS England.
This follows the initial licence for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) in 2020.
Darolutamide for mHSPC has been reviewed and approved by the MHRA through Project Orbis* which aims to accelerate the review and approval of promising cancer therapies.
The commercial agreement between NHS England and Bayer is the first for a prostate cancer therapy and enables early access for eligible NHS patients in England for this indication while the National Institute for Health and Care Excellence (NICE) completes its ongoing appraisal.
“The ARASENS trial has shown us that darolutamide + ADT in combination with docetaxel significantly increased overall survival in men with metastatic hormone sensitive prostate cancer” said Dr Ursula McGovern, FRCP PhD Consultant Medical Oncologist, University College London Hospitals NHS Foundations Trust and UK Chief Investigator in the study.
“Intensification of treatment was generally well tolerated, and this novel combination of treatments should be considered for appropriate patients with mHSPC.”
Today’s approval is founded on results from 1,305 patients who participated in the ARASENS clinical trial.3,4 This randomised, Phase III, multi-centre, double-blind, placebo-controlled trial was designed to investigate the efficacy and safety profile of oral darolutamide + ADT in combination with docetaxel in patients with mHSPC.
The below results showed that the combination treatment led to a statistically significant 32.5% reduced risk of death, with secondary endpoints being time to pain progression and time to first symptomatic skeletal event.
Overall incidence of adverse events (AEs) was similar between treatment arms, despite longer treatment exposure for those treated with darolutamide (median 41.0 versus 16.7 months).
“We are delighted that men with prostate cancer in England will have early access to another innovative treatment option,” said Antonio Payano, CEO Bayer UK & Ireland, adding: “It’s vital that NHS patients are able to benefit from the best standard of care and full range of emerging therapies today and in the future.
It requires direct and sustained collaboration between government, the NHS and the life sciences sector to properly realise these shared ambitions.”
Darolutamide was developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. The compound is also being investigated in further studies across various stages of prostate cancer.
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