Nubeqa treatment comes in combination with androgen deprivation therapy (ADT) and is indicated for metastatic hormone-sensitive prostate cancer. Credit: Shutterstock / JHVEPhoto

TheUS Food and Drug Administration (FDA) has accepted Bayer’s supplemental new drug application (sNDA) for its oral androgen receptor inhibitor (ARi), for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Dubbed Nubeqa but known generically as darolutamide, the treatment comes in combination with androgen deprivation therapy (ADT). The sNDA application is based on positive results from the company’s Phase III ARANOTE trial that previously saw the combination therapy meeting the trial’s primary endpoint in advancing radiological progression-free survival (rPFS).

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The treatment is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer.

The ARANOTE trial (NCT04736199) was a randomised, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of Nubeqa among a cohort of 669 patients randomised to receive 600mg of Nubeqa twice daily or matching placebo in addition to ADT. Results from the study were initially published in the Journal of Clinical Oncology.

Among some of the trial’s secondary endpoints included overall survival time, from randomisation to the date of the first castration-resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments.

Christine Roth, executive vice president at Bayer, said: “Bayer is dedicated to addressing unmet needs in prostate cancer treatment for various stages of the disease, and today’s acceptance of our sNDA application for Nubeqa plus ADT for the treatment of patients with mHSPC brings us closer to adding an additional treatment option for Nubeqa to benefit those living with mHSPC.

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“If approved, this would expand the indication for Nubeqa in patients with mHSPC to include Nubeqa both with and without chemotherapy, providing physicians and their patients with an additional Nubeqa treatment option in this setting. We are working closely with the FDA to bring this additional Nubeqa treatment option to patients as soon as possible.”

Bayer’s 2023 financial report detailed how therapy generated €869m ($949m) in sales last year. Research by GlobalData estimates that the company can expect to see Nubeqa sales rise to an estimated $3.6bn by the end of 2029.

GlobalData is the parent company of Clinical Trials Arena.

Elsewhere in the field of prostate cancer treatments, ESSA Pharma terminated the Phase II clinical trial of its own prostate cancer treatment, masofaniten, following an interim review.