Bayer, Orion’s Nubeqa gets approval in China for expanded use in prostate cancer

China’s National Medical Products Administration (NMPA) approved Bayer (OTCPK:BAYRY) (OTCPK:BAYZF) and Orion Corporation’s oral drug Nubeqa, in combination with docetaxel, to treat patients with metastatic hormone-sensitive prostate cancer (mHSPC).

The German conglomerate noted that Nubeqa (darolutamide) is already approved in China to treat patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing the disease spread which would spread to other parts.

“We are therefore delighted that patients in China will now have a new treatment option for metastatic hormone-sensitive prostate cancer that delays disease progression, extends survival and maintains quality of life,” said Christine Roth, member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology SBU at Bayer in a press release on Monday.

The approval was backed by data from a phase 3 trial called ARASENS, which showed that Nubeqa plus androgen deprivation therapy (ADT) in combination with chemotherapy docetaxel significantly reduced the risk of death by 32.5%, compared to ADT with docetaxel, in patients with mHSPC, the company noted.

Nubeqa sales in Q4 grew +129% Y/Y (+116% Fx & portfolio adj.) to €158M.

More on the company: SA contributor writes Bayer: Improving Business And Still Undervalued.