OncoPharm Darolutamide
Jul 31, 2019
The recent FDA approval of darolutamide marks a significant advancement in non-metastatic castrate-resistant prostate cancer treatment. The discussion highlights how it compares to other second-generation anti-androgens, like enzalutamide and apalutamide. Listeners will learn about differences in clinical efficacy and side effects. Additionally, the podcast dives into critical drug interactions with the cytochrome P450 enzyme system, emphasizing why understanding these interactions is vital for effective patient management.
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Definition And Trial Context For NMCRPC
- Non‑metastatic castrate‑resistant prostate cancer (NMCRPC) is defined by PSA progression on ADT with testosterone <50 ng/dL and no imaging metastases.
- Trials for enzalutamide, apalutamide, and darolutamide used similar inclusion criteria and metastasis‑free survival endpoints, so efficacy appears comparable across studies.
Dosing And Administration Differences
- Note dosing differences when choosing therapy: enzalutamide and apalutamide are once daily while darolutamide is twice daily.
- Take darolutamide with food to increase its low bioavailability two‑ to 2.5‑fold.
CNS Penetration Explains Safety Differences
- CNS penetration differs across the class: enzalutamide and apalutamide penetrate the blood‑brain barrier more than darolutamide in animal models.
- Lower CNS penetration with darolutamide may explain fewer seizures, falls, and possibly fewer fracture‑related harms.