Advanced Prostate Cancer Treatment Approved by TGA

Cube ( on behalf of Bayer)


New combination therapy for advanced prostate cancer

secures TGA registration

  • The TGA has registered NUBEQA® (darolutamide) in combination with two other therapies – signifying a new treatment approach for an advanced form of prostate cancer
  • Over 50 men are diagnosed with prostate cancer in Australia every day,1 and for half of them their cancer will spread to other parts of the body and become metastatic2
  • Due to the aggressive nature of metastatic prostate cancer and limited treatment options, the chance of survival is, historically, poor3

Sydney, 22nd March 2023 – Bayer Australia is pleased to announce the Therapeutic Goods Administration (TGA) has registered a second indication for NUBEQA (darolutamide), as a combination therapy for an advanced form of prostate cancer.

Taken as two tablets twice-daily, NUBEQA works by starving cancer cells of the hormones they need to grow and divide. In combination, the hormone therapy meanwhile blocks production of these cancer-stimulating hormones and chemotherapy aims to destroy cancer cells. With the addition of NUBEQA, the three treatments together target the disease from multiple angles.

First registered by the TGA for an early-stage form of prostate cancer in 2020, this new registration for NUBEQA will expand the drug’s use to metastatic hormone-sensitive prostate cancer (mHSPC). The TGA has registered NUBEQA, which can now be used in combination with the existing standard of care chemotherapy (docetaxel) and hormone therapy (androgen-deprivation therapy or ADT), giving clinicians a new treatment approach to address this challenging disease.

Men whose prostate cancer is detected early and contained within the prostate have a strong chance of survival; however, for men with metastatic disease, less than a third will survive beyond 5 years.4 This is mostly due to diagnosis happening late in the disease, the aggressive nature of the cancer and limited treatment options currently.5

Additional Facts:

  • Over 200,000 men are currently living with prostate cancer in Australia.8
  • This year, it’s estimated that more than 24,000 men will be diagnosed with the disease. 9
  • Every year approximately 3,500 lose their lives to the disease.9

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