BRIEF—FDA approves additional indication of Nubeqa

Germany’s Bayer announced on Friday that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) with docetaxel for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Bayer recently raised peak sales expectation for the oral androgen receptor inhibitor to in excess of three billion euros ($3.41 billion).

Nubeqa now has indications in both metastatic hormone-sensitive prostate cancer (mHSPC) and non-metastatic castration-resistant prostate cancer (nmCRPC).

The approval under the FDA’s Real-Time Oncology Review (RTOR) pilot program was based on the pivotal Phase III ARASENS trial, which showed a significant overall survival (OS) benefit with Nubeqa plus androgen deprivation therapy (ADT) and docetaxel compared to ADT and docetaxel.