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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