



Record of Telephone Conversation - Provenge, March 4, 2010



 
RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA    Submission ID: 125197/0    Office: OCTGT

Product:
 Sipuleucel-T

Applicant:
 Dendreon Corporation

Telecon Date/Time: 04-Mar-2010 11:00 AM        Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):
 1. Advice

 Author: LORI TULL
 Telecon Summary:
 Discussion of post marketing requirement
 FDA Participants: Lori Tull, Craig Zinderman, Peter Bross, Faith Barash, 
Chaohong Fan, Robert Wise, Wilson Bryan
 Non-FDA Participants: Liz Smith, Mark Frohlich, Jim Whitmore, Alison del Vento, 
Duyen Mai, Kathy Picha, Helen Kim
 Trans-BLA Group: No

 Related STNs: None

Related PMCs: None

Telecon Body:

CBER informed Dendreon that if the BLA were to be approved, then a post 
marketing study would need to be done to evaluate the small signal of possible 
increased risk of CVE in treated patients.  CBER commented that this was based 
on their assessment of all the data available, and that the CVE risk meets the 
criteria for a post marketing requirement (PMR).

CBER stated that the proposed registry design would likely be acceptable for the 
PMR.  CBER stated that Dendreon could choose to propose another study or refine 
the registry.
 CBER requested that Dendreon respond by next week with proposed dates for when 
they would submit the protocol, complete the study, and submit the final 
results, as well as their planned sample size.  Dendreon agreed to do so.

Dendreon asked if CBER had any comments on the proposal.  CBER responded that 
the design looked feasible.  CBER commented that in the analytic plan, the null 
hypothesis is the risk of stroke is not larger.  Dendreon should look for 
subsets that might have increased risk.  CBER suggested that Dendreon check the 
SEER data and examine variables and also note if there is past history of CVE.

Dendreon asked if the African American population was still a concern.  CBER 
responded that Dendreon should formulate a statement of hypothesis so CBER could 
evaluate it.  Dendreon asked if the African American study would be part of the 
requirement.  Dendreon stated that they would evaluate 200 patients and then 
reassess.

Dendreon asked if following patients for a minimum of three years would be 
acceptable.  CBER responded that it sounded reasonable.
 

   