The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Erleada (apalutamide; Janssen) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).

The approval was supported by data from the phase 3 TITAN study, involving 1052 patients with mCSPC. Patients were randomized 1:1 to receive either Erleada plus androgen deprivation therapy (ADT) or placebo plus ADT; ADT included a gonadotropin releasing hormone analogue or surgical castration. The primary end points were overall survival (OS) and radiographic progression-free survival (rPFS).

Results demonstrated Erleada plus ADT significantly extended OS compared with placebo plus ADT with a 33% reduction in the risk of death (hazard ratio [HR] 0.67; 95% CI, 0.51 to 0.89; P =.0053); a significant improvement in rPFS was also observed in the Erleada plus ADT treatment arm with a 52% reduction in risk of radiographic progression or death compared with placebo (HR 0.48; 95% CI, 0.39 to 0.60; P <.0001). Moreover, after a median follow-up of 22.7 months, the 2-year OS rates were 84% for Erleada plus ADT vs 78% for placebo plus ADT. Results from the study were published in The New England Journal of Medicine.

Regarding safety, the most common treatment-emergent adverse reactions reported with Erleada included fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.

“Prostate cancer is more difficult to treat once it spreads, and for patients with castration-sensitive disease, it is clear that ADT alone, is often not enough,” said Dr Kim Chi, Medical Oncologist at BC Cancer – Vancouver and principal investigator of the TITAN study. “Results from the TITAN study showed that, regardless of the extent of disease, patients with metastatic castration-sensitive prostate cancer have the potential to benefit from treatment with apalutamide in addition to ADT.”

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Erleada, an androgen receptor inhibitor, is already indicated for the treatment of non-metastatic, castration-resistant prostate cancer. It is supplied as 60mg tablets in 120-count bottles.

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