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  • "Excellent news": TGA approves drug for metastatic hormone-sensitive prostate cancer

    Author: Charlotte Mitchell

Experts have welcomed the Therapeutic Goods Administration’s approval of XTANDI (enzalutamide), an oral once-daily therapy delivering significant benefits for patients with metastatic hormone-sensitive prostate cancer.

Associate Professor Arun Azad, a medical oncologist from Peter MacCallum Cancer Centre, and a member of Australian New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) told HealthTimes that “new treatment options are very welcome for this group of patients.”

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“For many decades we had limited treatment options for men who have a cancer that has spread beyond the prostate but is still sensitive to hormone therapy. Androgen deprivation therapy (ADT) was the mainstay, but the development of treatment resistance is inevitable and, in some cases, very quick.”

“Now we are seeing additional effective oral medications being approved for these patients and that really is excellent news.”

“The advantage of using drugs like enzalutamide, in addition to ADT, is that you can control the cancer for longer. So, men can have longer survival, delayed progression and because you delay time to chemotherapy, we can preserve quality of life for longer as there is not that symptomatic progression.”


Cabrini Health
ACAS Assessor
St Vincent's Hospital

In the two major trials on enzalutamide, results have shown consistent benefits across all subgroups of men with metastatic prostate cancer and that's irrespective of disease volume, and whether they've had prior local therapy to their prostate with surgery and/or radiotherapy.

“We've seen that across the board, enzalutamide in addition to androgen deprivation therapy has delivered major clinical benefits”, Professor Azad said.

“A couple of important things to point out here is that this is not just a small improvement that we're seeing in the order of one or two months. There are people at the end of the trial who are coming back to the clinic and have still not had progression of their cancer 5, 6, 7 years later.”

“Obviously, that is not all patients, however there is no way that with ADT alone that those men would still be in remission or near remission state.”

Prostate Cancer Foundation of Australia CEO, Professor Jeff Dunn AO, welcomed the TGA’s approval saying, “this is a great step forward for Australian men and families impacted by prostate cancer and we commend Astellas and the TGA for responding to the evidence.”

XTANDI is manufactured by Astellas, whose Managing Director, Lizzie Marrett, commented that “we are excited to be adding another indication for enzalutamide and hope that this will make a meaningful difference to Australian men with metastatic hormone-sensitive prostate cancer”.

The Australian Institute of Health and Welfare estimates that in 2020 16,741 men were diagnosed with prostate cancer.1 It is estimated that up to one third of patients with prostate cancer will develop metastases at some point over their disease course.
Men diagnosed with metastatic hormone-sensitive prostate cancer tend to have a poor prognosis, with a median survival of approximately 3–4 years. This has long underscored the need for new treatment options.

“The introduction of drugs like enzalutamide, and other similar androgen receptor inhibitors, have really made a massive difference to the outcomes of these patients”, Professor Azad explained.

XTANDI is not currently reimbursed under the Pharmaceutical Benefits Scheme (PBS) for metastatic hormone-sensitive prostate cancer. In support of patient access and associated out-of-pocket costs, Astellas will make XTANDI available for this indication via a patient access program for patients.

“These treatments can be really transformative and having access to them in Australia via the PBS would really transform our practice and outcomes for people with prostate cancer”, Professor Azad said.


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Charlotte Mitchell

Charlotte is a published journalist and editor, with 10 years of experience in developing high-quality content for national and international publications.

With an academic background in both science and communications, she specialises in medical and science writing. Charlotte is passionate about creating engaging, evidence-based content that equips the community with important information on issues around healthcare, medicine and research.

Over the years, she has partnered with organisations including the Medical Journal of Australia, Cancer Council NSW, Bupa, the Australasian Medical Publishing Company, Dementia Australia, MDA National, pharmaceutical companies, and state and federal government agencies, to produce high-impact news and clinical content  for different audiences.