The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the use of Nubeqa® (darolutamide) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).1
The authorisation is based on positive results from the pivotal Phase III ARANOTE trial, evaluating the efficacy and safety of darolutamide plus ADT in patients with mHSPC. The trial showed that darolutamide plus ADT significantly improved radiological progression-free survival (rPFS), reducing the risk of radiological progression or death by 46% (HR 0.54; 95% CI 0.41–0.71; P<0.0001), compared to placebo plus ADT.4 The rPFS rates at 24 months were 70.3% in the darolutamide group and 52.1% in the placebo group. Consistent benefits in rPFS were observed across prespecified subgroups, including in patients with high-volume (HR 0.60; 95% CI 0.44-0.80) and low-volume (HR 0.30; 95% CI 0.15-0.60) mHSPC.4 The incidence of treatment-emergent adverse events (TEAEs) was similar between treatment groups.4 Treatment discontinuations due to TEAEs were lower in patients receiving darolutamide plus ADT compared to placebo plus ADT (6.1% vs 9.0%).4
"Despite significant advances in prostate cancer care, there is still a need for widening the options for men with advanced prostate cancer that can maintain quality of life as much as possible alongside improving their outcomes from prostate cancer, meaning more quality time overall. This means we have to adapt treatment to the individual person, taking into account other medical problems, such as medication, age and what their treatment goals and preferences are,” said Professor Alison Birtle, Consultant Clinical Oncologist at the Rosemere Cancer Centre, Lancashire Teaching Hospitals, Honorary Clinical Professor in the Faculty of Biology, Medicine & Health at the University of Manchester and Honorary Clinical Professor at The University of Central Lancashire. “Today’s authorisation of darolutamide plus ADT for use in metastatic hormone-sensitive prostate cancer provides me and other UK physicians with greater flexibility to tailor treatment to an individual patient's needs.”
“The authorisation represents an important development in treatment options for people living with metastatic hormone-sensitive prostate cancer in the UK. Our focus now is to ensure this new treatment option is available to patients and physicians as quickly as possible,” said Dr. Joep Hufman, Country Medical Director, Bayer UK & Ireland. “We remain committed to advancing treatment options for patients that address unmet needs across all stages of disease, which may help delay disease progression while maintaining quality of life.”
In the UK, prostate cancer is the most common cancer in men, with over 55,000 new cases identified each year.2 It accounts for nearly 28% of all new cancer diagnoses (2017 – 2019),2 highlighting the significant impact of this disease on public health. There are around 12,000 prostate cancer deaths in the UK every year – that’s 33 men every day (2017 – 2019), making it the second leading cause of cancer-related deaths in the country.2 The incidence of prostate cancer is expected to continue to rise by
15% in the UK2 due to an aging population and improved screening practices.6 While early-stage prostate cancer has a high survival rate, the challenges associated with advanced disease underscore the need for continued research and the development of future treatment options.7
“Advanced prostate cancer presents profound challenges that significantly affect not only patients but also their families. The emotional and psychological toll of a diagnosis of metastatic prostate cancer adds another layer of difficulty, often resulting in anxiety and distress. It is crucial that we continue to raise awareness and advocate for better access to timely diagnosis, effective treatments, and comprehensive support services that the patients and their families need to navigate this challenging journey,” said Oliver Kemp, CEO, Prostate Cancer Research.
Darolutamide was authorised in March 2020 in the European Union under the brand name Nubeqa® for the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.8 It was authorised in November 2022 in the UK for the treatment of adult patients with mHSPC in combination with ADT and docetaxel.9 In May 2023, the National Institute for Health and Care Excellence (NICE) issued guidance (TA903) recommending darolutamide plus ADT in combination with docetaxel as a treatment option for patients with mHSPC.10
ENDS