Following the news that Bayer’s androgen receptor inhibitor Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) and docetaxel has been approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) for use in patients with metastatic prostate cancer;

James Donagher, Oncology & Hematology Analyst at GlobalData, offers his view:

“Due to Japan’s ageing population, the number of diagnosed cases of prostate cancer will continue to escalate. Furthermore, many men will progress from metastatic hormone-sensitive prostate cancer (mHSPC) to metastatic castration-resistant prostate cancer (mCRPC), with a grim prognosis. Therefore, increasing the number of therapeutic options for mHSPC patients is imperative. This approval is based on excellent results from the pivotal Phase III ARASENS trial in which the combination of Nubeqa with ADT and docetaxel significantly lowered the risk of death by 35.2% in mHSPC patients compared to the placebo group.

“With Nubeqa already approved for treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) in Japan, Bayer extends its presence in the Japanese prostate cancer market with this further approval. GlobalData’s patient-based forecast predicts that this combination will garner $19.2 million in sales by 2028 in the mHSPC patient population in Japan. In addition, Nubeqa is in further prostate cancer trials both with different combinations (Nubeqa + ADT without chemotherapy) and in different patient populations (localized prostate cancer).”