From: Smith, Liz
To: Tull, Lori; Wise, Robert; Zinderman, Craig E;
cc: Bross, Peter F (CBER);
Subject: Follow-up to PV telecon
Date: Friday, March 26, 2010 6:00:29 PM
Dr. Wise –
Reference is made to the March 24, 2010 teleconference with members of FDA’s Office of Biometrics and Epidemiology and Dendreon. As requested, we are writing to further describe the overall design of the post-marketing Registry study for sipuleucel-T.
The final Registry study protocol, to be designated PROCEED (Provenge Registry for Observation, Collection, and Evaluation of Experience Data) will be submitted to FDA by June 30, 2010. The primary objective of this observational study will be to further evaluate the potential signal of cerebrovascular events (CVEs) following treatment with sipuleucel-T in men with metastatic castrate resistant prostate cancer (CRPC).
A minimum of 1500 patients will be enrolled to allow at least 80 percent power to detect relative risk ratio of 3 when comparing the incidence of CVE's in sipuleucel-T subjects in this registry to a suitably-chosen reference group.
As described in the original draft protocol, Dendreon intends to collect the following baseline prognostic variables for prostate cancer when available:
- Prostate specific antigen (PSA)
- Lactic dehydrogenase (LDH)
- Gleason score
- Alkaline phosphatase
- Eastern Cooperative Oncology Group (ECOG) performance status
- Presence of visceral metastases
- Number of bone metastases (05-, 6-10, >10)
- Localization of disease (bone only, bone and soft issue, soft tissue only)
Dendreon also plans to collect baseline risk factors for CVEs such as:
- Diabetes mellitus
- Cardiovascular disease
- Left ventricular hypertrophy
- Atrial fibrillation
- Prior history of stroke or transient ischemic attack
- Relevant concomitant medications
Please feel free to contact me or Liz Smith at (206) 829-1556 should you have any questions regarding information contained in this email.
Director, Regulatory Affairs
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