J&J's experimental use of Erleada in early-stage prostate cancer has shown promising yet mixed results in recent trials, particularly in high-risk localized or locally advanced disease.
*** In a large late-stage trial in high-risk localized or locally advanced prostate cancer, adding Erleada to standard hormone-blocking therapy (androgen deprivation therapy) before and after prostate surgery improved outcomes:**
patients were more than nine times more likely to have little or no detectable cancer in the prostate at surgery (8.9% vs about 1% in the hormone‑therapy‑alone group).* The combination also reduced the risk of disease progression or death by 20% and prolonged the time until patients needed further treatment by roughly double compared with hormone therapy alone.
Despite these clear benefits, questions remain amongst experts about the optimal treatment strategy:
* There is debate over whether an intensive, longer course of Erleada plus hormone therapy actually prevents cancer recurrence or simply delays it.* Some clinicians question whether the drug should be reserved for the highest-risk patients or broadly used, given the potential side effects such as fatigue, fractures, and heart-related problems associated with adding apalutamide to standard care.* The overall survival benefit and the risk–benefit balance for earlier-stage disease are still being evaluated, which may influence future guidelines and regulatory decisions.
Sources:
ERLEADA® (apalutamide) demonstrates statistically significant and ...
ERLEADA - ACIS Study - J&J Medical Connect
ERLEADA - LIBERTAS Study - J&J Medical Connect
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[PDF] Starting and Staying - erleada hcp
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Use of ERLEADA in Metastatic Castration-Resistant Prostate ...
J&J gets first-of-its-kind prostate cancer approval - BioPharma Dive