The US Food and Drug Administration (FDA) has approved Bayer’s oral androgen receptor inhibitor, Nubeqa (darolutamide), for use in patients with metastatic castration-sensitive prostate cancer (mCSPC).
This decision allows Nubeqa to be administered in combination with androgen deprivation therapy (ADT) for this condition.
The approval is supported by results from the Phase III ARANOTE trial, where the combination of darolutamide and ADT was shown to reduce the risk of radiological progression or death by 46% compared to a placebo combined with ADT.
This recent approval permits the use of Nubeqa plus ADT for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) in the US, either with or without the chemotherapy drug docetaxel.
Furthermore, Nubeqa is authorised for patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastases.
Bayer global product strategy and commercialisation executive vice president Christine Roth said: “Patients with mHSPC want treatments that delay disease progression and extend life – without compromising their ability to stay active.
“This approval, supported by compelling clinical data, reaffirms Nubeqa’s potential to become a leading therapy across various stages of prostate cancer, underscoring our commitment to deliver meaningful outcomes for patients and their loved ones.”
Prostate cancer ranks as the second most common cancer among men globally and is the fifth leading cause of cancer-related mortality in men. In 2022 alone, approximately 1.5 million men received a prostate cancer diagnosis, with around 397,000 fatalities reported worldwide.
Predictions indicate that these numbers could rise to 2.9 million cases by 2040.
Currently, Nubeqa’s approval extends to over 85 global markets for mHSPC treatment in combination with ADT and docetaxel. It is also approved in more than 85 countries for treating nmCRPC with ADT for patients at high risk of developing metastatic disease.
The European Union is currently processing an application for mHSPC treatment using Nubeqa and ADT without docetaxel.
Nubeqa, which recorded annual sales of €1.52bn in 2024, was developed in partnership between Bayer and Finnish pharmaceutical company Orion. The drug features a unique chemical composition that binds effectively to androgen receptors, counteracting their function and hindering the growth of prostate cancer cells.
Preclinical studies and human neuroimaging data suggest a low potential for blood-brain barrier penetration by darolutamide.
Darolutamide, combined with either ADT or ADT and docetaxel, demonstrated a comparable side effect profile in registration trials for mHSPC to other treatment arms.
