New treatment approval in Europe for men with non-metastatic castration-resistant prostate cancer

The European Commission has approved a new androgen receptor inhibitor (ARi) with a distinct chemical structure that delays disease progression, while minimizing the burdensome side effects of treatment, allowing men with non-metastatic castration-resistant prostate cancer (nmCRPC) to maintain their lifestyle without disruption. The therapy is already approved in the U.S. Australia, Brazil, Canada and Japan, and is under review with other health authorities worldwide.

What is nmCRPC?

Castration-resistant prostate cancer (CRPC) is an advanced form of the disease where the cancer keeps progressing even when the amount of testosterone is reduced to very low levels in the body. In Europe, over 67,000 men are estimated to have a CRPC diagnosis, based on 2018 prostate cancer incidence numbers.

nmCRPC is stage within CRPC, where the cancer has not spread beyond the prostate but has continued to progress, despite hormone therapy. About one-third of men with nmCRPC go on to develop metastases within two years,3 meaning the disease spreads beyond the prostate region, which is associated with increased morbidity and mortality, reduced patient quality of life, and increased healthcare costs.

What do the approvals of this new treatment mean for patients with nmCRPC?

Despite recent advances in nmCRPC treatment, there remains a high unmet need for new options that not only delay the time to metastases, but also limit the burdensome side effects of therapy, that can disrupt patients’ everyday lifestyle. This new approval means clinicians treating patients at this critical stage of prostate cancer now have a therapeutic option that significantly extends metastasis-free survival, with a favorable safety profile, helping men with nmCRPC maintain their active lifestyles and quality of life, even while on treatment.

Sources:

1. NUBEQA® Summary of Product Characteristics (SmPC), Bayer Pharma AG.

2. World Health Organization, GLOBOCAN 2018. Prostate fact sheet. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/27-Prostate-fact-sheet.pdf.

3. Kirby M. et al. Int J Clin Pract. 2011;65(11):1180-1192.doi:10.1111/j.1742-1241.2011.02799

4. Smith, M.R., Saad, F., Chowdhury, S. et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018;378:1408–1418.

5. Hussain, M., Fizazi, K., Saad, F. et al. Enzalutamide in men with nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2018;378:2465 - 2474.

6. Fizazi K, Shore N, Tammela T, et al. Darolutamide In Nonmetastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2019;380(7).

7. Hong J, Kim IY et al. Nonmetastatic Castration-Resistant Prostate Cancer. Korean J Urol. 2014;55(3):153. doi:10.4111/kju.2014.55.3.153.

8. Tannock et al. Docetaxel plus Prednisone or Mitoxantrone plus Prednisone for Advanced Prostate Cancer. N Engl J Med. 2004;351:1502-12. doi:10.1056/NEJMoa040720.