Pfizer and Astellas’ Xtandi (enzalutamide) has been recommended for approval by the European Medicines Agency’s advisory committee to treat high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC).
Following approval, the androgen receptor signalling inhibitor would become the first and only neo-adjuvant hormone therapy (NHT) available to treat this patient population in the EU.
Prostate cancer is currently the second most common form of cancer in men globally.
For nine out of ten patients, nmHSPC with a high-risk BCR will develop into a metastatic disease.
The Committee for Medicinal Products for Human Use (CHMP) recommended Xtandi as a monotherapy or in combination with androgen deprivation therapy for adult men with high-risk BCR nmHSPC who are unsuitable for salvage radiotherapy.
The decision was based on positive results from the phase 3 EMBARK trial, which were published in the New England Journal of Medicine and presented at the 2023 American Urology Association Annual Meeting.
The trial enrolled 1,068 patients with nmHSPC or non-metastatic castration-sensitive prostate cancer, with high-risk BCR at sites in the US, Canada, Europe, South America and the Asia-Pacific region.
EMBARK met its primary endpoint of metastasis-free survival (MFS) for Xtandi plus leuprolide, which demonstrated a statistically significant reduction in the risk of metastasis or death versus placebo plus leuprolide.
The study also met its key secondary endpoint after patients treated with Xtandi showed a statistically significant reduction in the risk of metastasis or death versus placebo plus leuprolide, meeting its MFS endpoint.
The CHMP’s positive opinion will now be reviewed by the European Commission and an EU marketing decision is expected by June 2024.
Ahsan Arozullah, senior vice president and head of oncology at Astellas, commented: “[The] positive opinion from the committee is an important step forward for providing an additional treatment option for these patients and… we look forward to Xtandi being… approved for this patient population in the EU.”
Xtandi has already received regulatory approvals in more than 90 countries, including the US, EU and Japan.
In November 2023, Xtandi was approved by the US Food and Drug Administration for the treatment of patients with nmHSPC and BCR at high risk for metastasis.