The National Institute of Health and Care Excellence (NICE) has reconsidered its previous decision for Janssen’s Erleada®▼ (apalutamide) and published two positive Final Appraisal Determinations (FADs) recommending it for use in combination with androgen deprivation therapy (ADT) to treat prostate cancer [3,4]. Apalutamide plus ADT is recommended for two indications within its marketing authorisation:
- As an option for treating hormone-sensitive metastatic prostate cancer (mHSPC) in adults, only if docetaxel is not suitable or cannot be tolerated.
- As an option for treating hormone-relapsed non-metastatic prostate cancer (nmHRPC)* that is at high risk** of metastasising in adults.
The decision means eligible prostate cancer patients with mHSPC and nmHRPC will now have access to apalutamide via the National Health Service (NHS) in England and Wales.
There are over 42,500 people diagnosed with prostate cancer each year in England and Wales. It is estimated that 13% have metastatic disease at diagnosis, and those with mHSPC also tend to have a poor prognosis, with a median overall survival (OS) of approximately 45 months in three large randomised controlled trials when starting standard androgen deprivation therapy (ADT) [6,7]. However, there are some patients who cannot tolerate or are unsuitable for docetaxel plus ADT .
NICE concluded that identifying people for whom docetaxel was contraindicated or unsuitable would be based on a clinical framework considering individual patient risk. Now apalutamide plus ADT has been recommended for use when docetaxel is unsuitable or cannot be tolerated, these patients can now access an alternative treatment option that is generally better tolerated than docetaxel plus ADT and is likely to be more effective than ADT alone.
NICE’s decision for mHSPC is based on data from the phase III TITAN study, which concluded that apalutamide plus ADT is clinically effective compared with placebo plus ADT . NICE also concluded that the data showed that median radiographic progression-free survival for people randomised to apalutamide plus ADT was not reached and for people randomised to placebo plus ADT, it was 22.1 months (hazard ratio 0.5, 95% CI 0.4 to 0.6).
Professor Amit Bahl, Consultant Clinical Oncologist and Uro-oncology Research Lead at Bristol Haematology & Oncology Centre said: “Despite significant advances in treatment options through research in advanced prostate cancer management, unfortunately in some patients the prognosis can be poor. The addition of apalutamide to the treatment pathway provides eligible prostate cancer patients with a therapy option with significant survival benefit as shown in clinical trials. It is a vital step towards improving outcomes in prostate cancer and enabling patients to have a better prognosis.”
Sarah Scanlon, Business Unit Director, Oncology, Haematology and Pulmonary Hypertension said: “Today’s positive recommendation for apalutamide marks a significant milestone in our mission to bring new therapeutic options to patients with mHSPC and nmHRPC. We are delighted that NICE has given the green light for apalutamide for both indications and look forward to seeing these groups of patients benefit from a new treatment option.”
 Chi, Kim N., et al. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. The New England Journal of Medicine, vol. 381, no. 1, 2019, pp. 13–24.
 Smith, Matthew R., et al. Apalutamide Treatment and Metastasis-Free Survival in Prostate Cancer. The New England Journal of Medicine, vol. 378, no. 15, 2018, pp. 1408–1418.
 National Institute for Health and Care Excellence. Final appraisal document. Apalutamide with androgen deprivation therapy for treating hormone-sensitive metastatic prostate cancer. Available at: https://www.nice.org.uk/guidance/gid-ta10423/documents/. Last accessed September 2021.
 National Institute for Health and Care Excellence. Final appraisal document. Apalutamide with androgen deprivation therapy for treating high-risk hormone-relapsed non-metastatic prostate cancer. Available at: https://www.nice.org.uk/guidance/gid-ta10423/documents/. Last accessed September 2021.
 Prostate Cancer UK. About Prostate Cancer. Available at: https://prostatecanceruk.org/prostate-information/about-prostate-cancer. Last accessed September 2021.
 European Association of Urology. Updated guidelines for metastatic hormone-sensitive prostate cancer: abiraterone acetate combined with castration is another standard. Available at: https://uroweb.org/wp-content/uploads/Mottet-N.-et-al.-Eur-Urol-733316-321.-Updated-Guidelines-for-Metastatic-Hormone-sensitive-PCa-Abiraterone-Acetate.pdf. Last accessed September 2021.
 National Prostate Cancer Audit. Annual Report 2020: Results of the NPCA Prospective Audit in England and Wales for men diagnosed from 1 April 2018 to 31 March 2019. January 2021. Available at: https://www.npca.org.uk/content/uploads/2021/01/NPCA-Annual-Report-2020_Final_140121.pdf. Last accessed September 2021.