Erleada Approved for Metastatic Castration-Sensitive Prostate Cancer

Phase 3 TITAN is the first registrational study to achieve statistical significance in dual primary endpoints of overall survival and radiographic progression-free survival in patients with metastatic castration sensitive prostate cancer (CSPC) regardless of extent of disease

The Janssen Pharmaceutical Companies of Johnson & Johnson announced on 9/17/19 that the U.S. Food and Drug Administration (FDA) has approved ERLEADA®

(apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).1

This new indication for ERLEADA® will make this androgen receptor inhibitor available for the approximately 40,000 people in the U.S. diagnosed with mCSPC annually.2

The approval was based on results from the Phase 3 TITAN study, which demonstrated significance overall survival (OS) and radiographic progression-free survival (rPFS) at the first planned analysis.3 The trial recruited patients regardless of extent of disease, including both high- and low- volume disease, or prior docetaxel treatment history.1,3

In the TITAN study, ERLEADA® plus ADT significantly increased OS compared to ADT alone with a 33 percent reduction in the risk of death.1 In addition, ERLEADA® plus ADT also significantly improved rPFS compared to ADT alone with a 52 percent lower risk of radiographic progression or death.1 Published results from the TITAN study, evaluating two-year OS rates after a median follow-up of 22.7 months, demonstrated 84 percent for ERLEADA® plus ADT compared to 78 percent for ADT alone.3

Dr. Kim Chi, a Medical Oncologist at BC Cancer (Vancouver) and principal investigator of the TITAN study stated that "Prostate cancer is more difficult to treat once it spreads, and for patients with castration-sensitive disease, it is clear that androgen deprivation therapy (ADT) alone, is often not enough," said. "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."

1 ERLEADA® Prescribing Information, September 17, 2019.

2 Supplement: Scher HI, Solo K, Valant J, Todd MB, Mehra M et al. Prevalence of Prostate Cancer Clinical States and Mortality in the United States: Estimates Using a Dynamic Progression Model. PLoS One. 2015; 10(10):1-2.

3 Chi, K. Apalutamide for Metastatic, Castration Sensitive Prostate Cancer. New England Journal of Medicine. Accessed September 2019.



https://www.janssen.com/us-fda-approves-supplemental-new-drug-application-snda-erleada-apalutamide-treatment-patients

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