Japan’s MHLW approved Nubeqa and Docetaxel combination for mHSPC

CAR-T Digest - August 2020

27 Feb 2023: Darolutamide (Oral) / Bayer / Orion Corporation: Received approval for mHSPC (ARASENS) in Japan

Japan’s MHLW (The Ministry of Health, Labor and Welfare) has approved the Nubeqa + ADT in combination with Docetaxel for mHSPC (metastatic hormone-sensitive prostate cancer)
- The MHLW approval is based on the positive results from the Phase 3 ARASENS trial, which demonstrated that Nubeqa + ADT + Docetaxel significantly reduced the risk of death by 32 .5% compared to ADT + Docetaxel, in patients with mHSPC
This is the second indication for Nubeqa since its approval for nmCRPC back in Jan 2020 in Japan
- The combination received US FDA approval for mHSPC in Aug 2022
- In the EU, it recently received a positive CHMP opinion, and approval is expected by the end of Q1 2023