Application submitted to MHLW for additional indication of Nubeqa in Japan.- Bayer

The application seeks marketing authorization for darolutamide in combination with docetaxel and androgen deprivation therapy (ADT) for the treatment of patients with prostate cancer with distant metastasis. Darolutamide is already marketed under the brand name Nubeqa for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.

The MHLW submission is based on positive results from the pivotal Phase III ARASENS trial recently presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) and published in The New England Journal of Medicine.(previously cited).

Results demonstrated a statistically significant improvement in overall survival for darolutamide plus ADT and docetaxel compared to ADT plus docetaxel in men with metastatic hormone-sensitive prostate cancer (mHSPC).