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  • Nubeqa¡¯s indication expanded to msHPC in combo with ADT
  • by Whang, byung-woo | translator Alice Kang | Jun 24, 2025 06:00am
Approved as part of a 2-drug combination therapy with ADT for metastatic hormone-sensitive prostate cancer
Reduces the risk of radiographic progression or death and improves quality of life
Enables personalized treatment for patients according to the patient¡¯s various stages of prostate cancer
 ¡ã Pic of Nubeqa
Bayer Korea announced on the 23rd that its oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) has been approved by the Ministry of Food and Drug Safety as part of a two-drug regimen in combination with androgen deprivation therapy (ADT) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).

With this expanded indication, Nubeqa can now be used not only as part of a three-drug regimen with ADT and the chemotherapy drug docetaxel but also as part of a two-drug regimen with ADT.

This enables more flexible treatment approaches tailored to the individual condition and treatment goals of mHSPC patients.

The approval was based on the results of the ARANOTE study, a global Phase III cli
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