NICE backs Bayer’s Nubeqa for prostate cancer

24 October 2025

The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending the use of German drugmaker Bayer’s (BAYN: DE) Nubeqa (darolutamide) in combination with ADT as an option for treating adult patients with mHSPC who are unsuitable for chemotherapy (docetaxel).

The decision means eligible prostate cancer patients with mHSPC will now have access to darolutamide plus ADT through the National Health Service (NHS) in England and Wales.

Today’s decision by the NICE follows the recent authorization of the indication in June by the Medicines and Healthcare products Regulatory Agency (MHRA) and is based on positive results from the pivotal Phase III ARANOTE trial, evaluating the efficacy and tolerability profile of darolutamide plus ADT in patients with mHSPC.

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