Astellas Pharma Inc. announced the acceptance by the European Medicines Agency (EMA) of a Type II Variation Application for regulatory review for the use of XTANDI™ (enzalutamide) in metastatic hormone-sensitive prostate cancer (mHSPC) patients.
Assessment by the EMA means the Committee for Medicinal Products for Human Use (CHMP) will evaluate the Type II Variation Application for enzalutamide and provide a Scientific Opinion on whether the medicine may be authorised for this new indication, following 90 days of assessment.
“When prostate cancer begins to spread to other parts of the body, it can be an acutely distressing time for patients. As well as the emotional burden this places on them, daily life can be impacted by debilitating symptoms of progressing cancer, such as pain,”
said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas.
“We look forward to the CHMP’s opinion as we continue to address the unmet medical need for men with advanced prostate cancer by providing additional treatment options across the disease continuum.”
The Type II Variation Application is based on data from both the pivotal Phase 3 ARCHES trial, and the Phase 3 ENZAMET trial, investigating enzalutamide in men with mHSPC.
The data from the ARCHES trial were presented in an oral session at the 2019 Genitourinary Cancers Symposium in San Francisco (Abstract #687), and demonstrated that enzalutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression by 61% versus placebo plus ADT in men with mHSPC (n=1,150; HR=0.39 [95% CI: 0.30-0.50]; P<0.0001). In the ARCHES trial, enzalutamide demonstrated a safety profile which was consistent with previous trials in castration-resistant prostate cancer (CRPC). Grade 3-4 adverse events (AEs) (defined as severe/disabling or life-threatening) were similar for patients receiving both enzalutamide plus ADT and those who received placebo plus ADT (23.6% vs. 24.7%).
Data from the ENZAMET trial, organised by the international research group Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) Ltd., demonstrated a 33% decrease in the risk of death in men with mHSPC receiving enzalutamide plus ADT compared to those who took a conventional non-steroidal antiandrogen (NSAA) plus ADT (n=1,125; HR=0.67 [95% CI: 0.52-0.86]; P=0.002).
Overall survival (OS) at 3 years was 80% for patients receiving enzalutamide plus ADT versus 72% receiving NSAA plus ADT. AEs during the follow-up period were consistent with the stage of disease, the age of the patients, and known safety profiles of the trial regimen. The incidence of seizure and fatigue were higher with enzalutamide plus ADT and treatment discontinuation due to AEs was more frequent among patients taking enzalutamide than with NSAA plus ADT. Astellas provided funding and support for the ENZAMET trial.
Enzalutamide is currently approved in Europe for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC) and adult men with metastatic castration-resistant prostate cancer (mCPRC) in whom chemotherapy is not yet clinically indicated, or following disease progression on or after docetaxel therapy. In the U.S. and Japan enzalutamide is indicated for the treatment of CRPC.