Bayer Receives Approval for Third Indication of Nubeqa™ in Advanced Prostate Cancer
Wednesday, June 04, 2025
Bayer has received approval from the U.S. Food and Drug Administration (FDA) for a new indication of its oral androgen receptor inhibitor, Nubeqa™ (darolutamide).
Prostate cancer is the second most common cancer and a leading cause of cancer-related deaths among men globally. In 2022, approximately 1.5 million men were diagnosed, and nearly 397,000 died due to the disease. These numbers are expected to rise significantly by 2040.
mHSPC refers to prostate cancer that has spread beyond the prostate and still responds to hormone therapy. Despite treatment advances, the disease often progresses to a castration-resistant stage with limited survival prospects.
Nubeqa has already been approved in more than 85 countries for the treatment of mHSPC in combination with ADT and docetaxel, as well as for nmCRPC.
Darolutamide is an oral androgen receptor inhibitor with a structure that allows it to bind strongly to the androgen receptor, preventing its activity and slowing the growth of prostate cancer cells. Preclinical and imaging studies also suggest it has minimal penetration of the blood-brain barrier.
The ARANOTE trial was a randomised, double-blind, placebo-controlled Phase III study involving 669 patients with mHSPC.
The treatment, when combined with androgen deprivation therapy (ADT), is now approved for use in adults with metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC).
This approval follows the positive outcome of the Phase III ARANOTE trial, which demonstrated that Nubeqa in combination with ADT reduced the risk of radiological progression or death by 46% compared to placebo plus ADT. The results confirmed consistent benefits across subgroups with both high- and low-volume mHSPC.
With this development, Nubeqa in combination with ADT is now indicated in the U.S. for treating adults with mHSPC, either with or without prior treatment with docetaxel. Nubeqa is also approved for adults with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.
The drug is developed jointly by Bayer and Orion Corporation, a pharmaceutical company based in Finland.
Source: bayer.com
