

Telecon - Provenge, April 14, 2010

 
(System Info - 126650 Benton Kimberly 04/22/2010 08:04:00 TULL)

Telecon
 April 14, 2010, 3:30 p.m.

Dendreon participants: Helen Kim, Karen Krstulich
 FDA participants:  Keith Wonnacott, Thomas Finn, Kimberly Benton

FDA initiated this telecon to request that Dendreon prepare a proposal for CMC 
information to be submitted post licensure.  The discussion involved the types 
of data FDA wishes to receive, including summaries, in tabular or graphical 
form, of lot release testing data for all lots of sipuleucel-T; lots that do not 
complete manufacturing and the reason, the number of aphereses required 
performed per patient and the reason when more than 3; data trending; and 
actions taken as a result of observed trends. 

It was agreed that submission of this information on a yearly basis was an 
acceptable period, and for convenience this could be included in the BLA Annual 
Report.  It was agreed that this would be documented as a Post Marketing 
Commitment if an approval letter were to be issued. 

Dendreon agreed to discuss this request internally and follow with statement of 
commitment submitted as an amendment to the BLA. 
 

   