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Table 1 Docetaxel and NHA approval dates and indications in mHSPC

From: Impact of next-generation hormonal agents on treatment patterns among patients with metastatic hormone-sensitive prostate cancer: a real-world study from the United States, five European countries and Japan

Drug name Country Approval date Indication
Docetaxel US N/A N/A
EU (EMA) [25] Sept 2019 In combination with ADT, with or without prednisone or prednisolone, are indicated for the treatment of patients with mHSPC
Japan N/A N/A
Abiraterone US (FDA) [17, 22] Feb 2018 In combination with prednisone for the treatment of high-risk patients with mHSPC
EU (EMA) [15] Nov 2017 In combination with prednisone or prednisolone for the treatment of newly diagnosed high risk mHSPC in adult men in combination with androgen deprivation therapy (ADT)
Japan (MHLW) [23] Feb 2018 For the treatment of hormone-naïve prostate cancer (HNPC) with high risk prognostic factors
Apalutamide US (FDA) [19] Sept 2019 For the treatment of patients with mHSPC
EU (EMA) [16] Jan 2020 Adult men with mHSPC in combination with ADT
Japan (MHLW) [24] May 2020 For the treatment of men with prostate cancer with distant metastases
Enzalutamide US (FDA) [18] Dec 2019 For the treatment of patients with mHSPC
EU (EMA) [21] May 2021 For the treatment of patients with mHSPC
Japan (MHLW) [20] May 2020 For the treatment of prostate cancer patients with distant metastasis
  1. US United States, EU Europe, EMA European Medicines Agency, FDA Food and Drug Administration, MHLW Japan Ministry of Health, Labour and Welfare