Dr Hwang on FDA-Approved Agents for nmCRPC


Clara Hwang, MD, highlights agents that the FDA has approved for use in patients with nonmetastatic castration-resistant prostate cancer, such as apalutamide, enzalutamide, and darolutamide.

Clara Hwang, MD, medical oncologist, senior staff physician, Henry Ford Health System, clinical assistant professor, Wayne State University School of Medicine, highlights agents that the FDA has approved for use in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC), such as apalutamide (Erleada), enzalutamide (Xtandi), and darolutamide (Nubeqa).

For patients with nmCRPC, apalutamide, enzalutamide, and darolutamide were all approved by the FDA based on clinical trial data from the phase 3 SPARTAN (NCT01946204), PROSPER (NCT02003924), and ARAMIS (NCT02200614) trials, respectively, that demonstrated their metastasis-free survival (MFS) benefits vs placebo, Hwang begins. Furthermore, these 3 agents are also associated with overall survival (OS) benefits compared with placebo, Hwang explains. This is good news for patients who do not have other effective therapies to delay metastasis, delay the morbidity associated with metastasis, and improve survival, she emphasizes.

One remaining challenge regarding these 3 FDA-approved drugs is how to differentiate between them, Hwang says. No head-to-head comparisons between these agents have been conducted, Hwang expands. However, oncologists can try to compare these agents’ adverse effect (AE) profiles, tolerability, and, to some degree, efficacy, to determine the optimal therpay for each patient, Hwang emphasizes. All 3 agents improve MFS, as well as OS. Moreover, patients can remain on these treatments for many years, and typically receive treatment with these agents for 3 or 4 years before they experience disease progression, Hwang notes.

Apalutamide, enzalutamide, and darolutamide have similar efficacy profiles. However, each agent is associated with unique AEs, Hwang continues. For example, apalutamide is associated with a rash that typically is not seen with either enzalutamide or darolutamide. Notably, darolutamide, based on its structure, does not appear to cross the blood-brain barrier as much as enzalutamide, and thus may be less associated with central nervous system toxicities, such as cognitive AEs or seizures, Hwang concludes.

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