Astellas secures new indication for prostate cancer drug

Astellas Xtandi (enzalutamide) is now TGA registered for a new indication for patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with biochemical recurrence at high-risk for metastasis (high-risk BCR).

Prostate cancer is the most commonly diagnosed cancer in Australia and is the second most common cause of death from cancer in Australian men, behind lung cancer.

“Although prostate cancer is the most commonly diagnosed cancer in Australia, there still exist challenges when it comes to treatment equity and access,” said Professor Henry Woo, Professor of Urology at the College of Science and Medicine of the Australian National University. “Expanding the use of enzalutamide so it can be used in an earlier prostate cancer treatment setting, is a step forward in treatment access for Australian men.”

Of men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience biochemical recurrence (BCR) within 10 years. About nine out of 10 men with high-risk BCR will develop metastatic disease, and one in three will die as a result of their metastatic prostate cancer.

The new indication is based on results from the Phase 3 EMBARK trial. The trial demonstrated that enzalutamide, both in combination with leuprolide and as monotherapy, significantly improved metastasis-free survival in men with high-risk biochemical recurrence of prostate cancer, compared to leuprolide alone.

Professor Woo, who was involved in the EMBARK trial, said “For men with high-risk recurrent prostate cancer, conventional androgen-deprivation therapy offers some benefit, but disease progression remains inevitable. The addition of enzalutamide significantly delays the onset of metastatic disease and is likely to extend survival, without the cost of diminishing quality of life.”

“There is a likely correlation between metastasis-free survival and overall survival. In the EMBARK study, the use of enzalutamide plus leuprolide or enzalutamide monotherapy resulted in longer metastasis-free survival, which is a very promising outcome.”

Vinod Shetty, Head of Medical Affairs, Astellas Pharma APAC, said “With Xtandi now an option for men with high-risk biochemical recurrence, we are redefining prostate cancer treatment. This milestone is a culmination of years of research and development and we are excited to bring this treatment to more prostate cancer patients who can benefit.”

“From the patients’ perspective, when prostate cancer progresses, it can cause loss of energy, pain and loss of function. A treatment that can delay the development of cancer progression by delaying metastatic disease will positively impact the quality of life of these patients,” stated Professor Woo.

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