News >

FDA Approval Sought for Apalutamide in Metastatic Castration-Sensitive Prostate Cancer

Gina Columbus @ginacolumbusonc
Published: Monday, Apr 29, 2019

Craig Tendler, M

Craig Tendler, MD

A supplemental new drug application (sNDA) has been submitted to the FDA for the approval of apalutamide (Erleada) for use as a treatment of patients with metastatic castration-sensitive prostate cancer, according to Janssen, the manufacturer of the next-generation androgen receptor inhibitor.1

 

References

  1. Janssen Submits Application to U.S. FDA Seeking Approval of ERLEADA®(apalutamide) for Patients with Metastatic Castration-Sensitive Prostate Cancer. Janssen. Published April 29, 2019. https://bit.ly/2V4efcv. Accessed April 29, 2019.
  2. Janssen Announces ERLEADA®(apalutamide) Phase 3 TITAN Study Unblinded as Dual Primary Endpoints Achieved in Clinical Program Evaluating Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer. Janssen. Published January 30, 2019. https://bit.ly/2UuyCL1. Accessed January 30, 2019.
  3. Small EJ, Saad F, Chowdhury S et al. SPARTAN, a phase 3 double-blind, randomized study of apalutamide (APA) versus placebo (PBO) in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC). J Clin Oncol. 2018;36(suppl 6s; abstract 161).

... to read the full story
To Read the Full Story

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Community Practice Connections™: 3rd Annual International Congress on Oncology & Pathology™Aug 30, 20201.5
Community Practice Connections™: ASCO Direct™ Highlights – 2019 Official Annual Meeting ReviewAug 30, 20201.5
Publication Bottom Border
Border Publication
x