BERLIN (dpa-AFX) - Bayer has achieved a trial success with its prostate cancer drug Nubeqa. The active ingredient darolutamide met the primary endpoint in the Phase III Aranote study in patients with metastatic hormone-sensitive prostate cancer, the pharmaceutical and agrochemical company announced on Wednesday. The drug in combination with hormone therapy significantly extended radiographic progression-free survival (rPFS) compared to placebo. Applications to extend the approval of Nubeqa are now planned, it added.

Analyst Emily Field from the British bank Barclays explained in a study in mid-June that the success of this study would significantly expand the addressable patient population in view of the frequency of metastases. The study would close a data gap, especially as some doctors have already started to use the drug off-label. This means that a drug is prescribed for a different clinical picture or in a different dosage than the approval actually provides for.

Nubeqa is already approved in many countries in combination with hormone therapy and chemotherapy for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). The drug is also used to treat patients with non-metastatic castration-resistant prostate cancer with a high risk of developing metastases (high-risk mCRPC). Sales of the still young drug grew strongly in 2023 and are expected to break the billion mark in 2024./mis/jha/