Nubeqa gains additional indication in Japan

27 February 2023

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the oral androgen receptor inhibitor (ARi) darolutamide plus ADT in combination with docetaxel in the indication of metastatic prostate cancer.

Darolutamide, trade named Nubeqa and developed jointly by Germany’s Bayer (BAYN: DE) and Finland’s Orion Corporation (Nasdaq: OMX), is already authorized in Japan for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

Last year, Bayer raised peak global sales expectation for the oral androgen receptor inhibitor from 1 billion euros to in excess of 3 billion euros ($3.2 billion). Nubeqa competes with big-hitting androgen receptor inhibitors Xtandi (enzalutamide) and Erleada (apalutamide), developed respectively by Pfizer (NYSE: PFE) and Astellas (TYO: 4503), and Johnson & Johnson (NYSE: JNJ).

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