A new era in prostate cancer therapy, says medical oncologist

Pharma News: Janssen’s nonsteroidal antiandrogen therapy is now listed on the Pharmaceutical Benefits Scheme (PBS) for approximately 1,000 men with non-metastatic prostate cancer (nmCRPC) who despite treatment with testosterone-lowering medication experience a rapid rise in prostate specific antigen (PSA) levels, signalling the imminent spread of cancer. Erlyand (apalutamide) will be prescribed in combination with androgen deprivation therapy (ADT).

Prostate Cancer Foundation of Australia welcomed the news that the life-extending drug would be made available to men with high-risk forms of prostate cancer.

“This PBS listing is an important development, and our message is clear – early diagnosis, early treatment and early identification of changes in cancer activity are key to containing and combatting prostate cancer,” said PCFA CEO Anne Savage.

Without listing on the PBS, this oral therapy – a competitor to Pfizer and Astellas’ Xandi – would cost consumers around $40,000 a year.

Associate Professor Arun Azad from Peter MacCallum Cancer Centre said the PBS listing heralds “a new era in the treatment of prostate cancer where doctors pre-empt the spread of cancer. Stopping cancer before it spreads represents a shift in how we treat prostate cancer. It’s akin to identifying and dowsing flames before they form and spread as a bushfire.”

Erlyand’s green light follows the phase 3 Titan trial, which showed Erlyand plus androgen deprivation therapy (ADT) cut the risk of death over placebo plus ADT by 33%. After nearly two years, 84% of patients on Erlyand-ADT were still alive, compared with 78% of the placebo-ADT group.

Associate Professor Azad explained that while there were treatments for advanced prostate cancer, suppressing the cancer at an earlier stage is a more effective strategy which avoids “fighting the cancer on multiple fronts”.

“Wherever possible we want to stop the spread of cancer. We now have treatment options that can be used earlier with the aim of preventing further spread of disease,” he said.

A rapid doubling of PSA levels in the blood indicates that men with non-metastatic prostate cancer are at heightened risk of their cancer spreading. 

“This is a red flag that signals a need for change in treatment,” Associate Professor Azad explained.

Associate Professor Azad said that a decline in men participating in PSA testing due to COVID-19 had been concerning and would undoubtedly mean more men being diagnosed with advanced prostate cancer.

Janssen Australia and New Zealand Managing Director, Biljana Naumovic said the company had been “working to secure a PBS listing since 2018. It’s been a long wait and the implications on the health of men with non-metastatic prostate cancer cannot be underestimated.

“This is why the Federal Government’s review of National Medicines Policy (NMP) must remove the barriers to timely and equitable access to innovative medicines.”

Earlier this year Janssen also presented real-world data in metastatic castration-sensitive prostate cancer (mCSPC) demonstrating that the majority of patients achieved over 90% decline in PSA by six months after initiation of Erlyand.

Ms Naumovic confirmed that Janssen continues to explore the use of Erlyand at different stages in the prostate cancer treatment journey.

“We are hopeful that Erlyand will play an important role in combatting various forms of prostate cancer.”

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