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.


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“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.

For more information visit erleada.com.