Nubeqa registered by TGA for new patient group


Australia’s Therapeutic Goods Administration (TGA) has registered a second indication for NUBEQA (darolutamide), as a combination therapy for an advanced form of prostate cancer.

Prostate Cancer Foundation of Australia (PCFA) has welcomed the TGA decision.

“This is an important development for Australian men and families facing advanced prostate cancer and we hope to see the drug made available soon via the Pharmaceutical Benefits Scheme for men with metastatic hormone-sensitive prostate cancer,” said PCFA Chief Executive Officer Anne Savage.

“We commend the TGA for its action to give Australian men better prospects for slowing down the spread of prostate cancer. In consultation with prostate cancer consumers, Australian men and their loved ones overwhelmingly agree that access to essential treatment like this can help to allay some of the fears men hold that their disease could rapidly spread, significantly improving their quality of life and sense of hope.”

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

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.

While clinicians may immediately prescribe NUBEQA to eligible patients with mHSPC privately, affordable access via the Pharmaceutical Benefits Scheme (PBS) remains the next ambition for Bayer. As Bayer waits for its submission for reimbursement to be evaluated, it is initiating a patient access program for eligible mHSPC patients.

Oncologist Professor Arun Azad, from Peter MacCallum Cancer Centre, Melbourne, believes the expansion of NUBEQA’s indication and the use of a new combination approach will come as great news to men whose prostate cancer has spread.

“Prostate cancer generally has a good chance of survival, as it can be closely monitored, and you can intervene early with treatment options. However, with metastatic disease, once the cancer has spread, things become a lot more challenging. When we find the disease after it has become metastatic, it’s referred to as ‘de-novo’, and represents around 45% of metastatic cases.6 The de-novo form of mHSPC is aggressive and associated with worse survival rates,”7 commented Prof. Azad.

“This TGA registration of NUBEQA in mHSPC is important, because it offers a large group of men, who previously had very few treatment options, access to an effective new treatment. As soon as metastatic disease is detected, there is no need to delay and we can initiate treatment.”

Bayer Pharmaceuticals has also welcomed the news.

“Prostate cancer has now overtaken breast cancer as Australia’s most-diagnosed cancer and, particularly in its advanced form, is rapidly emerging as a national health priority, with daily calls for better diagnosis and treatment options,” said Bayer Pharmaceuticals ANZ General Manager, Ashraf Al-Ouf.

“We hope that the TGA’s registration of NUBEQA in mHSPC, along with the news of our access program for eligible patients currently suffering from this disease, can become the first steps toward improved outcomes for these men.”


As with all medicines, NUBEQA is associated with some side-effects. While uncommon, the most frequent adverse events are fatigue, rash, or pain in an extremity. The most frequently observed adverse events in patients with mHSPC receiving NUBEQA in combination with docetaxel were constipation, decreased appetite, rash and hypertension. NUBEQA is not suitable for patients with hypersensitivity to the medicine or other substances in the tablet, or in women who are or may become pregnant. Caution is required in patients who have recently suffered a cardiovascular event, or who have impaired liver or kidney function, and in those under 18 years of age.10 The following medicines may influence the effect of NUBEQA, or NUBEQA may influence the effect of these medicines: rifampicin (antibiotic), carbamazepine and phenobarbital (epilepsy), St. John’s Wort (anxiety or low mood), rosuvastatin, fluvastatin and atorvastatin (high cholesterol), methotrexate (joint and/or skin inflammation, or cancer), and sulfasalazine (inflammatory bowel disease).


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  3. Sayegh, N., et al., Recent Advances in the Management of Metastatic Prostate Cancer, January 2022. JCO Oncology, doi 10.1200/OP.21.00206
  4. Chambers S.K., et al., Experiences of Australian men diagnosed with prostate cancer: A qualitative study February 2018, BMJ Open, doi: 1136/bmjopen-2017-019917
  5. Prostate Cancer: Types of Treatment, September 2021. Available at: Last accessed November 2022
  6. Borno H.T. et al., Examining initial treatment and survival among men with metastatic prostate cancer: An analysis from the CaPSURE registry, October 2020, Urologic Oncology, doi: 1016/j.urolonc.2020.07.012
  7. Finianos A. et al., Characterization of Differences Between Prostate Cancer Patients Presenting With De Novo Versus Primary Progressive Metastatic Disease, August 2017, Clinical Genitourinary Cancer. org/10.1016/j.clgc.2017.08.006
  8. Prostate Cancer Foundation Australia. Myth Busters Poster. Available at: Last accessed November 2022
  9. Prostate Cancer in Australia statistics, 2022. Available at: Last accessed November 2022
  10. NUBEQA Consumer Medicine Information (CMI) Summary. Available at: Last accessed December 2022

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