Erleada® is the commercial brand name of Apalutamide Tablets, an orally active next-generation androgen receptor inhibitor developed by Janssen. It binds competitively to androgen receptors, inhibits androgen receptor nuclear translocation and DNA binding, and blocks androgen-mediated oncogenic signaling to suppress prostate cancer cell proliferation.
Main Indications
Treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC);
Treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis.
Clinical Research
Global multicenter phase III SPARTAN pivotal trial fully validated significant metastasis-free survival benefit of apalutamide versus placebo for high-risk nmCRPC patients;
Global multicenter phase III TITAN trial confirmed remarkable overall survival improvement for patients with metastatic hormone-sensitive prostate cancer receiving apalutamide combined with androgen deprivation therapy;
Long-term open-label extension cohorts demonstrated sustained anti-tumor control under continuous once-daily oral administration;
Dose-finding research verified balanced anti-tumor efficacy and systemic safety profile of the 60mg once-daily standard dose;
Chinese domestic registration trials confirmed consistent therapeutic activity and manageable adverse reaction spectrum for domestic prostate cancer populations.
Common Side Effects
Common mild adverse reactions: Fatigue, hypertension, rash, arthralgia, fall and diarrhea;
Laboratory abnormalities: Transient mild elevation of liver transaminases;
Severe but uncommon risks: Seizure, ischemic cardiovascular events, fracture, thyroid dysfunction and pruritus.
Approval Status in China
Original drug Erleada® (Apalutamide Tablets) was officially approved for marketing in China in 2019, with the specification of 60mg per tablet, 120 tablets per bottle/box. It is currently a prescription targeted anti-prostate cancer drug included in China’s Category B medical insurance catalogue.
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