Bayer has secured the European Commission (EC) marketing authorisation for Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT).
The combination is indicated to treat metastatic hormone-sensitive prostate cancer (mHSPC) in the European Union (EU).
Nubeqa, an oral androgen receptor inhibitor, was developed by Bayer in collaboration with Finnish pharmaceutical company Orion.
Its unique chemical structure enables high-affinity binding to androgen receptors, effectively inhibiting receptor function and the growth of prostate cancer cells.
Preclinical models and neuroimaging data in healthy humans indicate the drug’s low potential for blood-brain barrier penetration.
Nubeqa is already approved in over 85 countries for use with ADT and docetaxel in mHSPC, and with ADT alone in non-metastatic castration-resistant prostate cancer (nmCRPC).
ARANOTE trial principal investigator Fred Saad said: “Today’s approval of darolutamide plus ADT means that it can now be used with or without chemotherapy, offering physicians greater flexibility to tailor treatment plans to meet the unique needs of their patients and improve clinical outcomes for men with mHSPC.
“Results from the ARANOTE trial demonstrate that darolutamide plus ADT delays disease progression and extends survival, and just as importantly, due to its high tolerability, enables patients to maintain their daily living with minimal disruption.”
The EC approval is based on positive outcomes from the Phase 3 ARANOTE trial, a randomised, double-blind, placebo-controlled study.
The trial assessed the efficacy and safety of Nubeqa plus ADT in 669 patients with mHSPC, who received 600mg of Nubeqa twice daily or a placebo alongside ADT.
Results showed that Nubeqa plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT.
Nubeqa’s tolerability profile and limited risk of interactions with other medications present an advancement in treatment management for physicians and patients.
Consistent benefits in radiographic progression-free survival (rPFS) were observed across prespecified subgroups, including patients with high-volume and low-volume mHSPC.
Nubeqa plus ADT was generally well tolerated, showing lower discontinuation rates due to adverse events compared to placebo plus ADT.
Bayer global product strategy and commercialisation executive vice president and pharmaceuticals leadership team member Christine Roth said: “The third European approval of darolutamide represents a significant step forward for men with advanced prostate cancer.
“Darolutamide is the first androgen receptor inhibitor to show clinically meaningful health-related quality of life benefits, offering patients an effective and well-tolerated treatment.
“Backed by compelling clinical data from the ARANOTE, ARASENS, and ARAMIS trials, we believe darolutamide has the potential to become a leading therapy across various stages of prostate cancer.”
