CLINICAL STUDY REPORT INFORMATION

SPARTAN, the phase 3 registration trial, evaluated the efficacy and safety of ERLEADA in patients (N=1207) with non-metastatic castration-resistant prostate cancer.¹ In an effort to increase transparency in the drug approval process, the Food and Drug Administration (FDA) launched the Clinical Data Summary Pilot Program on January 16, 2018. In the pilot, the FDA planned to post parts of clinical summary reports (CSRs) from up to nine New Drug Applications (NDAs) whose sponsors volunteered to participate in the program.^2,3 One sponsor (Janssen Biotech) voluntarily agreed to participate.⁴

Relevant dates related to the Clinical Data Summary Pilot Program are summarized below:

• January 16, 2018: The FDA launched the pilot program.²
• June 26, 2019: The recruitment phase concluded and the evaluation phase began.³
• June 27, 2019: A Federal Register notice seeking pilot feedback was published by the FDA.⁴
• March 26, 2020: The FDA announced the conclusion of the pilot program.³

CSRs are comprised of summaries of clinical information used in making market approval decisions.³ Specific parts of the CSR, including the study report body, the protocol and amendments, and the statistical analysis plan, were posted for the SPARTAN study as part of this pilot.

The clinical study report, protocol, and statistical analysis plan for the SPARTAN study remains posted and can be found at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/Erleada_210951_toc.cfm (scroll to the “Sponsor Clinical Study Reports ARN-509-003 SPARTAN NCT # 01946204” section at the bottom of the web page).