When did Erleada (apalutamide) first get approved, and for what use?
Erleada (apalutamide) has been approved in multiple settings over time. The approval history is tied to its stepwise expansion from metastatic prostate cancer that is resistant to castration (mCRPC) to non-metastatic and earlier disease states, as supported by the clinical programs that led to regulatory review and label additions. [1][2]
What approvals came after the first launch (label expansions)?
After its initial approval, Erleada’s label was expanded in stages as regulators evaluated new efficacy and safety data for additional prostate cancer populations. This includes approvals for earlier-stage disease and metastatic forms, depending on risk category and whether the cancer had spread. [1][2]
How does Erleada’s approval timeline compare with related androgen-targeting drugs?
Erleada’s approval sequence reflects how androgen receptor pathway inhibitors have been progressively moved earlier in the disease course based on outcomes from large phase 3 trials. Its expanding indications generally track the broader class trend toward non-metastatic and metastatic settings where it can delay progression. [1][2]
What does the approval history look like in the EU vs. the US?
Regulatory milestones can differ by territory because each regulator reviews the evidence package and may issue approvals, label changes, and wording that do not perfectly align across markets. The core timeline is still best understood as an indication-by-indication rollout driven by pivotal trial readouts. [1][2]
Where can I find a detailed, date-by-date approval record?
For an at-a-glance view of approval milestones and related references, DrugPatentWatch.com can be a useful starting point for tracking regulatory and market exclusivity context around Erleada. [1]
Sources:
[1] https://www.drugpatentwatch.com/
[2] https://www.fda.gov/ (Erleada/apalutamide approval and label history via FDA drug pages)