Janssen Pharmaceuticals announced new scientific evidence showing that the use of apalutamide leads to a rapid and profound prostate-specific antigen (PSA) response in patients with metastatic castration-sensitive prostate cancer (mCSPC). In a post-hoc analysis of data already obtained from the Phase 3 registration studies, human response was found to be associated with improvement in patient-reported outcomes (PROs) in terms of quality of life, physical well-being, pain and the intensity of fatigue. The findings are to be presented at the upcoming American Society of Clinical Oncology’s Genitourinary Cancer Symposium in San Francisco. The study included data from 186 apalutamide-treated patients and 165 enzalutamide-treated patients from 69 urologists in the United States. Patients included in the analysis had at least 12 months of clinical activity to assess baseline characteristics. They were classified into treatment cohorts based on their first filled prescription for apalutamide or enzalutamide after December 16, 2019. Patients were followed from the date of their first filled prescription until discontinuation of regimen, change of treatment, end of clinical activity or end of data available for analysis. “This analysis shows that the rapid and profound prostate-specific antigen (PSA) responses shown in the pivotal studies improve patients’ quality of life,” summarized Dr. Tracy McGowan, a member of the pharmaceutical company’s team. “We are committed to continuously expanding the body of information about the action of apalutamide. This can help patients and their treating doctors decide on a treatment that works best for them,” added Dr McGowan. The active substance apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) in adult men. in combination with androgen deprivation therapy. Apalutamide has been approved by the American Food & Drug Administration for nmCRPC since February 14, 2018, and for mCSPC since September 17, 2019. To date, more than 50,000 patients worldwide have treated with apalutamide. Sources: New ERLEADA® (apalutamide) Analysis Demonstrates Rapid, Deep Prostate-Specific Antigen (PSA) Response in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC). (February 14, 2022). Janssen. Pharmaceutical Companies of Johnson&Johnson – https://www.janssen.com/new-erleadar-apalutamide-analysis-demonstrates-rapid-deep-prostate-specific-antigen-psa-response Erleada, INN-apalutamide. European Medicines Agency. (January 14, 2019) – https://www.ema.europa.eu/en/documents/product-information/erleada-epar-product-information_bg.pdf
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