Newswire (Published: Friday, September 27, 2019, 7:31:00 AM CDT, Received: Friday, September 27, 2019, 8:00:49 AM CDT)

Word Count: 330

This milestone highlights Janssens commitment to improve the standard of care HORSHAM, Pa., September 17, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson announced today 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).[i] Todays approval follows FDA Priority Review Designation of the supplemental New Drug Application (sNDA) that was submitted in April 2019 and reviewed through the FDA Real-Time Oncology Review program. The 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.[ii]

Approval is based on results from the Phase 3 TITAN study, which achieved statistical significance in the dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) at the first pre-planned interim analysis.[iii] The trial recruited patients regardless of extent of disease, including both high- and low- volume disease, or prior docetaxel treatment history.1,3 Results were presented in an oral session at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine.

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 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.

In the TITAN study, ERLEADA plus ADT significantly extended OS compared to placebo plus ADT with a 33 percent reduction in the risk of death (HR=0.67; 95 percent CI, 0.51-0.89; P=0.0053).1 ERLEADA plus ADT also significantly improved rPFS compared to placebo plus ADT with a 52 percent lower risk of radiographic progression or death (HR=0.48; 95 percent CI, 0.39-0.60; P

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