Apalutamide Trade Name
The trade name for apalutamide is ERLEADA® 1.
Key Product Information
ERLEADA (apalutamide) is manufactured by Janssen-Cilag Ltd. (Johnson & Johnson) and is available as oral film-coated tablets in two strengths 1, 2:
- 240 mg tablets (standard dose formulation)
- 60 mg tablets (for dose flexibility)
The standard therapeutic dose is 240 mg once daily (four 60 mg tablets), administered orally 3, 4.
FDA Approval Timeline
ERLEADA received FDA approval for:
- February 2018: First global approval for non-metastatic castration-resistant prostate cancer (nmCRPC) 3, 5
- September 2019: Expanded approval for metastatic castration-sensitive prostate cancer (mCSPC) 6, 4
Clinical Context
Apalutamide is a nonsteroidal androgen receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR, with 7- to 10-fold greater affinity compared to first-generation antiandrogens like bicalutamide 3. It represents a category 1, preferred treatment option in current NCCN and AUA guidelines for appropriate patient populations 4, 7.