Bayer: third indication requested in China for Nubeqa

(CercleFinance.com) - Bayer announced on Tuesday that it had submitted an application to the Chinese health authorities for approval of Nubeqa in the treatment of metastatic castration-sensitive prostate cancer (mCSCC)

The application concerns the registration of this tablet, an androgen receptor (AR) inhibitor, in combination with antiandrogen therapy (AAT).


This is the third indication filed for Nubeqa, already approved in China for metastatic castration-sensitive prostate cancer (mCSCC) in combination with TAA and docetaxel.

The drug is also approved in the country for the treatment of non-metastatic castration-resistant prostate cancer.

Bayer says it bases its application on a Phase III study, which showed that compared with the placebo/antiandrogen therapy (TAA) combination, the Nubeqa-TAA combination reduced the risk of disease progression or death by 46%.

Darolutamide - or Nubeqa by its trade name - is being developed by Bayer in collaboration with the Finnish pharmaceutical company Orion.


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