NICE recommends Bayer’s NUBEQA®▼ (darolutamide) + ADT in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC)

• More prostate cancer patients in England and Wales will now have access to NUBEQA, following the few hundred patients1 who have already received the medication through the early access agreement between Bayer and NHS England²
• The decision from NICE follows the accelerated regulatory approval by MHRA under Project Orbis* in November 2022.³ Darolutamide + androgen deprivation therapy (ADT) in combination with docetaxel was the first triple combination treatment made available by the NHS in England for patients with mHSPC³
• Darolutamide + ADT in combination with docetaxel demonstrated a statistically significant reduction in risk of death in patients with mHSPC, as well as several improvements in secondary endpoints^4,5

Reading, UK, 19^th May 2023 – Bayer today announces that the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending darolutamide + ADT in combination with docetaxel as a treatment option for patients with mHSPC.⁶

Following darolutamide’s approval by the Medicines and Healthcare products Regulatory Agency (MHRA) for mHSPC patients in November 2022,³ Bayer announced a commercial agreement with the NHS in England to ensure clinicians could arrange early access.² Since November 2022, a few hundred eligible patients with mHSPC have received the medication in England.¹ Today’s decision by NICE allows additional eligible patients with mHSPC in England and Wales to receive this medication.

Dr Simon Hughes, Consultant Clinical Oncologist, Guy’s and St Thomas’s NHS Foundation Trust, said: “When prostate cancer has spread to other parts of the body we have limited treatment options that are both effective and well tolerated. We welcome today’s NICE recommendation that extends the availability of darolutamide, in England and Wales, to patients with metastatic hormone-sensitive prostate cancer, in addition to the existing indication for patients with non-metastatic hormone-resistant prostate cancer. Oncologists now have an additional treatment option to offer to their patients.”

The decision by NICE is based on the results from 1,305 patients who participated in the ARASENS clinical trial.^4,5 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. Results showed that the combination treatment led to a statistically significant 32.5% reduced risk of death, with secondary endpoints being time to castration-resistant prostate cancer (CRPC), time to pain progression and time to first symptomatic skeletal event, measured at 12-week intervals.^4,5 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).^4,5

Chiara De Biase, Director of Support & Influencing at Prostate Cancer UK, said: “We are extremely pleased that men can now start to benefit from this brand-new combination treatment, giving hundreds of men each year another option which has been shown to help them live longer. This is the first triple therapy of its kind to be made available on the NHS for prostate cancer, blazing a trail for more new combination treatments that have the potential to be even more effective in the future. The next step in our work will be to help establish which men most benefit from this approach, so that every man receives precise therapies tailored to his disease.”

“The positive recommendation by NICE paves the way for additional eligible patients in England and Wales to benefit from this innovative medication, following the early access we agreed with NHS England approximately 6 months ago,” said Antonio Payano, CEO Bayer UK & Ireland, adding: “We remain committed to investigating the potential of darolutamide in prostate cancer with additional clinical trials and working with the relevant UK authorities to help make it available to as many eligible patients as possible.”

Darolutamide was developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. It is currently approved for the treatment of patients with mHSPC in combination and docetaxel and patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.³ It is also being investigated in further studies across various stages of prostate cancer.

* Project Orbis is an initiative of the FDA Oncology Center of Excellence, providing a framework for concurrent submission and review of oncology products among international partners.