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FDA Approves Apalutamide for Type of Prostate Cancer
On September 17, 2019, the FDA approved apalutamide (Erleada; Janssen Biotech) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
Apalutamide received initial approval for the treatment of patients with non-metastatic castration-resistant prostate cancer in 2018.
The efficacy of this drug was demonstrated in the TITAN trial, which randomized 1052 patients with mCSPC to apalutamide 240 mg daily or placebo. All patients were treated with androgen deprivation therapy (ADT).
The major efficacy outcomes were overall survival (OS) and radiographic progression-free survival (rPFS).
At the time of a pre-specified interim analysis, the hazard ratio for OS was 0.67 (95% CI: 0.51, 0.89; P=0.0053), but median OS was not reach in either arm. The hazard ratio for rPFS improvement was 0.48 (95% CI: 0.39, 0.60; P<0.0001). The median rPFS was 22.1 months in the placebo arm and not reach in the apalutamide arm.
The most common adverse events associated with apalutamide (incidence ≥10%) were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.—Janelle Bradley
