Bayer announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the approval of Nubeqa in a third indication for advanced prostate cancer.
This positive opinion concerns the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with anti-androgen hormone therapy (ADT).
Bayer says that this combination reduced the risk of radiographic disease progression or death by 46% in Phase III clinical trials compared to placebo and ADT.
The German pharmaceutical group adds that the CHMP's positive opinion reinforces Nubeqa's potential to become a standard treatment for various stages of prostate cancer, with or without chemotherapy, thereby expanding the therapeutic options available to physicians.
The European Commission's final decision on marketing authorization is expected in the coming months.
It should be noted that the US Food and Drug Administration (FDA) has also just approved Nubeqa for this indication.
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