On September 17, 2019, the Food and Drug Administration approved apalutamide (ERLEADA, Janssen Biotech, Inc) for patients with metastatic castration-sensitive prostate cancer (mCSPC). Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer.

Efficacy was demonstrated in TITAN (NCT02489318), a randomized, double-blind, placebo-controlled, multi-center clinical trial enrolling 1,052 patients with mCSPC. Patients received either apalutamide 240 mg daily or placebo, orally. All patients received androgen deprivation therapy (ADT)—either concomitant gonadotropin-releasing hormone analog or prior bilateral orchiectomy. Patients with both high- and low-volume disease were enrolled in the study.

Statistically significant improvements in both major efficacy outcomes of overall survival (OS) and radiographic progression-free survival (rPFS) were demonstrated. 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); however, median OS was not reached in either arm. The hazard ratio for the rPFS improvement was 0.48 (95% CI: 0.39, 0.60; p<0.0001). The median rPFS was not reached for the apalutamide plus ADT arm, and was 22.1 months for the placebo plus ADT arm.

The most common adverse reactions (incidence ≥10%) for patients who received apalutamide were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.

The recommended dose of apalutamide is 240 mg (four 60 mg tablets) orally once daily, with or without food. Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

View full prescribing information for ERLEADA.

This review used the OCE’s Real-Time Oncology Review (RTOR) pilot program and its accompanying Assessment Aid. This application was approved 6 weeks prior to its FDA goal date.

FDA granted this application a priority review. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

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For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

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