The approval was based on the results from the Phase 3 EMBARK trial which met its primary endpoint of metastasis-free survival for the Xtandi plus leuprolide arm
Astellas' Xtandi earns EC approval in an additional early prostate cancer treatment setting. (Credit: Julia Koblitz on Unsplash)
Astellas Pharma has received the European Commission (EC) approval for the use of Xtandi (enzalutamide) in an additional treatment setting for recurrent early prostate cancer.
The EC has approved Xtandi as monotherapy or alongside androgen deprivation therapy (ADT) to treat adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are not eligible for salvage-radiotherapy.
It follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in March.
The extended approval is based on the findings from the double-blind, placebo-controlled, multi-national Phase 3 EMBARK trial, led by Astellas and Pfizer.
It randomised 1,068 patients to get enzalutamide 160mg daily plus leuprolide, enzalutamide 160mg as a single agent, or placebo plus leuprolide.
According to the results, EMBARK met its primary endpoint of metastasis-free survival (MFS) for the Xtandi plus leuprolide group.
The patients who received Xtandi along with leuprolide had a 57.6% lower risk of cancer spreading or death compared to those who received leuprolide only.
Additionally, participants treated with enzalutamide alone saw a 36.9% decrease in risk, meeting the key secondary endpoint.
Astellas senior vice president and oncology development head Ahsan Arozullah said: “This expanded approval for Xtandi is a vitally important advance for patients with nmHSPC with high-risk BCR and is a testament to our long and ongoing collaboration with a global network of dedicated clinical trial investigators, patient groups, clinical trial participants and their families.
“Efficacy and safety results from the EMBARK study demonstrate the potential for Xtandi as a new option for treatment in the early, recurrent hormone-sensitive prostate cancer setting.”
Developed by the Japanese pharma firm and Pfizer, Xtandi is an androgen receptor signalling inhibitor.
It is currently approved for one or more indications in over 90 countries, including the US, European Union, and Japan.
The US Food and Drug Administration (FDA) authorised Xtandi in November last year to treat patients with BCR-positive, non-metastatic castration-sensitive prostate cancer who are at high risk of metastasis.
In January, EC approved Pfizer’s Talzenna (talazoparib) in combination with Xtandi to treat adult patients with certain prostate cancer.