New prostate cancer drug approved in Australia prompts funding debate

There are 50 men diagnosed with prostate cancer in Australia every day – now a new drug therapy is offering hope for those with the most deadly form.

Musician David Cosma, with son Charlie, 8, and Georgie, 11, is taking a new prostate cancer drug that has just been approved in Australia. Picture: David Caird

A new drug is available in Australia from Wednesday for men battling the most deadly form of advanced prostate cancer.

The Therapeutic Goods Administration (TGA) has registered the drug darolutamide (sold as Nubeqa) for men with advanced metastatic hormone-sensitive prostate cancer. The drug is taken as a tablet twice daily and works by starving cancer cells of the hormones they need to grow and divide.

Metastasis means the cancer has spread to a different part of the body from where it started.

The drug has been approved for use as a “triplet therapy” where it is taken in combination with chemotherapy and a hormone therapy injection.

It is this method that a major international study confirms not only extends life, but improves a patient’s quality of life.

More than 1300 men worldwide, including patients from Australia, took part in the ARASENS trial published in the New England Journal of Medicine a year ago. Further promising results were published last month.

The trial involved men with metastatic hormone-sensitive prostate cancer and found survival was significantly longer for those on the triplet therapy of darolutamide combined with androgen-deprivation therapy and chemotherapy.

Prostate cancer patients now have access to a new pill to help treat the disease. Picture: iStock

While the Bayer-made drug has been available in Australia since 2020 for prostate cancer before it has spread, today it has been given the green light for use in men with more advanced disease.

Musician David Cosma is one of the first Australians to try the new drug therapy and says so far it is doing its job.

Husband to Sharon and dad to Georgie (11) and Charlie (8), the singer songwriter says his atest Prostate-Specific Antigen (PSA) results on Monday confirm it remains good news.

PSA is a blood test that can monitor men after surgery or radiation therapy for prostate cancer to see if their cancer has recurred.

“The PSA is now 0 which is really great; it is stopping the cancer from growing, it is doing its job with me at the moment,” he said.

Oncologist Professor Arun Azad from the Peter MacCallum Cancer Centre and the University of Melbourne says the TGA registration is important.

“It offers a large group of men, who previously had few treatment options, access to an effective new treatment,” he says.

He said when metastatic disease is detected, there is now no need to delay treatment.

“You get a lot of bang for your buck if this cancer is treated aggressively earlier and while potentially more expensive for the Federal Government to reimburse, we see the benefits. This one is better if used earlier rather than later.”

David Cosma with his wife Sharon Parker and kids Georgie, 11, and Charlie, 8. Picture: David Caird

Until the drug is listed on the Pharmaceutical Benefits Scheme (PBS), darolutamide would cost a prohibitive $40,000 a year for patients.

In a statement Bayer Australia says affordable access via the PBS remains its next ambition and while waiting for its submission for funding to be evaluated by the PBS, it is introducing an access program for eligible patients.

This temporary solution would allow those patients who are fit enough to tolerate the triplet therapy to access the drug for free, but clinicians hope the new drug therapy can be quickly funded for all eligible patients as it is now in the US and UK.

Professor Azad says there will definitely be patients asking for the drug from today, but that the cost would be prohibitive for some.

“We need to get these drugs into clinics earlier, particularly where there is evidence for that

approach; the approval for darolutamide in this setting is a perfect example of having a therapy approved but still requiring an access program for patients,” he said.

“We can’t cure metastatic (prostate) cancer, but with this new therapy we can make patients livelonger and live well, that’s still a good outcome.”

AT A GLANCE

• More than 200,000 Australians live with prostate cancer

• It is the most common cancer in Australia with around 50 men diagnosed every day

• It is estimated that one in six men will be diagnosed by the time they are 85