FDA Approval Announcement
HORSHAM, Pa., Sept. 17, 2019 /PRNewswire/ -- 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). Today's 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.
Basis for Approval: Phase 3 TITAN Study
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. The trial recruited patients regardless of extent of disease, including both high- and low-volume disease, or prior docetaxel treatment history. 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.
Expert Commentary on Clinical Significance
"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."
Key Efficacy Results from the TITAN Study
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). 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<0.0001). As reported in the published results from the TITAN study, the two-year OS rates, after a median follow-up of 22.7 months, were 84 percent for Erleada plus ADT compared to 78 percent for placebo plus ADT.
Janssen Statement on Treatment Advancement
"Erleada has the potential to change how patients with prostate cancer are treated, regardless of the extent of the disease or prior docetaxel treatment history, by delaying disease progression and prolonging survival," said Margaret Yu, M.D., Vice President, Prostate Cancer Disease Area Leader, Janssen Research & Development, LLC. "This milestone highlights Janssen's commitment to improve the standard of care for patients with prostate cancer as we continue to develop innovative treatments across the disease continuum."
Common Adverse Reactions
The most common adverse reactions (≥10 percent) that occurred more frequently in Erleada treated patients (≥2 percent over placebo) from the randomized placebo-controlled clinical trials (TITAN and SPARTAN) were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.
