LEVERKUSEN (dpa-AFX) - Bayer AG (BAYZF.PK) Monday said that the European Commission has granted marketing authorization for Nubeqa in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
The approval is based on positive results from the Phase III ARANOTE study, which showed that Nubeqa plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT in patients with mHSPC.
Nubeqa, jointly developed with Orion Corporation, is already approved in more than 85 countries for use with ADT and chemotherapy drug docetaxel in mHSPC, and with ADT alone in non-metastatic castration-resistant prostate cancer (nmCRPC).
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