- XTANDI is now the first and only novel hormone therapy available for the treatment of high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer in the European Union (EU)
- XTANDI can be given alone or in combination with androgen deprivation therapy
- Approval is based on results from the positive Phase 3 EMBARK study which showed XTANDI alone or in combination with leuprolide reduced the risk of metastasis or death
The extended approval for XTANDI is based on results from the Phase 3 EMBARK trial in 1,068 men with high-risk BCR nmHSPC, in whom levels of prostate-specific antigen (PSA), the biomarker which can be indicative of prostate cancer activity, doubled in nine months or less. The study showed patients treated with XTANDI in combination with leuprolide had a 57.6% lower chance of their cancer spreading or dying compared to those treated with leuprolide alone. Participants who were treated with XTANDI alone had a 36.9% reduction in risk.1
The European Association of Urology (EAU) revised their treatment guidelines in April 2024, recommending enzalutamide for men with high-risk BCR nmHSPC with or without ADT, after radiation therapy or surgery. Up until now, there has been no consensus on the standard of care for men in this setting.2
Dr. Antonio Alcaraz, Chairman of the Department of Urology at the University Hospital Clinic of Barcelona:
“When non-metastatic hormone-sensitive prostate cancer recurs and is allowed to evolve, it could potentially lead to metastasis. Facing a particularly high risk and poorer outcomes in this stage of prostate cancer are men with a rapidly rising PSA, where PSA levels double within 9 months. It is critical to manage the cancer carefully then, and I urge clinicians not to delay treatment in this setting. With this expanded approval for enzalutamide, clinicians now have an important new option to treat men with non-metastatic hormone-sensitive prostate cancer at high risk of metastasizing, which could become a new standard of care.”
Ernst-Günther Carl, Chairman, Europa Uomo:
“There is a desperate need for additional effective treatment options for those living with advanced prostate cancer. Many men with hormone-sensitive prostate cancer undergo arduous surgery and rounds of radiotherapy, which can be a successful way to keep their cancer at bay. It is devastating then, when up to four in ten of those will go on to develop a recurrence that puts them at significantly greater risk of their cancer spreading and early death. The patient community welcomes any ongoing therapeutic research advances that may benefit those living with prostate cancer in progress.”
Ahsan Arozullah, MD, MPH, Senior Vice President and Head of Oncology Development, Astellas:
“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. Astellas is in active discussions with regulatory authorities around the world to bring XTANDI to those who may benefit.”The EC approval follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in March 2024, recommending approval of XTANDI in the high risk BCR nmHSPC setting.3
XTANDI was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with non-metastatic castration-sensitive prostate cancer (nmCSPC; also known as nmHSPC) with BCR at high risk for metastasis in November 2023.
Astellas will reflect the impact from this matter in its financial forecast of the fiscal year ending March 31, 2025, that is scheduled to be disclosed on April 25, 2024.
For more information, please see the press releases “Astellas Receives Positive CHMP Opinion for XTANDITM in Additional Recurrent Early Prostate Cancer Treatment Setting” issued on March 25, 2024, and “European Medicines Agency Validates Type II Variation for Astellas' XTANDI® (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence” issued on September 12, 2023.
- Freedland SJ, et al. Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer. N Engl J Med. 2023;389:1453-146.
- European Association of Urology (EAU). EAU Guidelines: Prostate Cancer. Available at: https://d56bochluxqnz.cloudfront.net/documents/full-guideline/EAU-EANM-ESTRO-ESUR-ISUP-SIOG-Guidelines-on-Prostate-Cancer-2024.pdf. Accessed: April 24, 2024.
- European Medicines Agency. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP). March 18-21, 2024. Available at: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-march-2024. Accessed: April 24, 2024.