
 
  


Follow-up to PV Telecon - Provenge, March 26, 2010

 
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
  Hemoglobin
  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:
  Hypertension
  Diabetes mellitus
  Smoking
  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.

Helen Kim
Director, Regulatory Affairs
Dendreon Corporation
(W) 206.829.1464
(C) 206.227.8893
(F) 206.441.4070
hkim@dendreon.com 


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