- NUBEQA® (Darolutamide) + Androgen Deprivation Therapy (ADT) in combination with docetaxel is the first prostate cancer treatment to be made available by the NHS in England through an early national access agreement, following accelerated regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA) under Project Orbis*1
- Bayer has entered a commercial agreement with NHS England - the first healthcare system in Europe to fast-track the medicine - which ensures clinicians can arrange early access for their eligible patients in England while NICE completes its assessment2
- The approval comes after the presentation of the ARASENS Phase III clinical trial data at the 2022 ASCO GU Cancers Symposium in February 2022 and their simultaneous publication in The New England Journal of Medicine3,4
Bayer today announces that 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.2 This follows the initial licence for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) in 2020.5
Darolutamide for mHSPC has been reviewed and approved by the MHRA through Project Orbis* which aims to accelerate review and approval of promising cancer therapies.1 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. 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.3,4
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).3,4
“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.
References:
1. Project Orbis, https://www.gov.uk/guidance/guidance-on-project-orbis#contents, Last accessed: November 2022
2. NHS England – News: https://www.england.nhs.uk/news/
3. Smith, RA, et al. Overall survival with darolutamide versus placebo in combination with androgen-deprivation therapy and docetaxel for metastatic hormone-sensitive prostate cancer in the phase 3 ARASENS trial. Oral Abstract session at the ASCO GU Cancers Symposium, 17-19 February 2022, San Francisco, California, USA. Available at: https://meetings.asco.org/abstracts-presentations/205326 Last accessed: November 2022.
4. Smith, RA, et al. Darolutamide and survival in metastatic hormone-sensitive prostate cancer. NEJM 2022 Feb 17, doi:10.1056/NEJMoa2119115.
5. NUBEQA® (darolutamide) 300 mg film-coated tables Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/11324 Last accessed: November 2022.
6. Cancer Research UK. Prostate cancer statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/prostate-cancer? Last accessed: November 2022.
7. Prostate Cancer UK. Advanced prostate cancer: your questions answered about the disease affecting Bill Turnbull. Available at: https://prostatecanceruk.org/about-us/news-and-views/2018/10/advanced-disease-blog Last accessed: November 2022
8. Cancer.Net. ASCO answers: Prostate Cancer. Available at: https://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf Last accessed: February 2022.
9. Cattrini, et al. Current Treatment Options for Metastatic Hormone-Sensitive Prostate Cancer. Cancers.2019 11(9), p.1355.
10. Ritch, C. and Cookson, M. Recent trends in the management of advanced prostate cancer. F1000Res. 2018 Sep 21;7:F1000 Faculty Rev-1513.