- The FDA has approved an expanded indication for apalutamide, allowing its use for metastatic castration-sensitive prostate cancer (mCSPC).
Why this matters
- Apalutamide was initially approved in 2018 for patients with nonmetastatic castration-resistant prostate cancer.
- Apalutamide is effective regardless of disease burden; patients now have options in this setting.
- Approval was based on the randomized, double-blind placebo-controlled TITAN study (N=1052) of patients with mCSPC receiving apalutamide 240 mg daily or placebo.
- Patients with both high- and low-volume disease were enrolled.
- At interim analysis, apalutamide significantly prolonged OS (HR, 0.67; P=.0053).
- Median OS was not reached in either group.
- Apalutamide also prolonged radiographic PFS (median, not reached vs 22.1 months; HR, 0.48; P<.0001>
- Adverse events most commonly (≥10%) included fatigue, arthralgia, rash, decreased appetite, fall, weight decrease, hypertension, hot flush, diarrhea, and fracture.
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