Bayer's innovative combination therapy submits application for additional indications in Japan

Bayer has announced that it has submitted an additional indication application for the oral androgen receptor inhibitor (ARi) darolutamide to the Japanese Ministry of Health, Labour and Welfare (MHLW), seeking approval for darolutamide in combination with Docetaxel and androgen deprivation therapy (ADT) in patients with prostate cancer with distant metastases

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide

Dalotamide has a unique chemical structure and can bind to androgen receptor with high affinity, showing strong antagonistic activity, thereby inhibiting receptor function and growth of prostate cancer cells

This application submission is based on positive results from a pivotal Phase 3 clinical trial and has been published in the New England Journal of Medicine

In addition, the trial met a number of secondary endpoints, including delaying the conversion of patients to castration-resistant prostate cancer and delaying the onset of pain progression

▲The overall survival data of this phase 3 clinical trial (Image source: Reference [2])

References:

[1] Bayer submits application for additional indication of Nubeqa™ (darolutamide) in Japan.

[2] Smith et al.

(Original abridged)