
 

Record of Telephone Conversation - Provenge, April 23, 2010


 
RECORD OF TELEPHONE CONVERSATION

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

Product:
Sipuleucel-T

Applicant:
Dendreon Corporation

Telecon Date/Time: 23-Apr-2010 01:30 PM        Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):
1. Advice

Author: LORI TULL

Telecon Summary:
SPL dosage units, PMC proposal, and label revisions

FDA Participants: Kimberly Benton, Wilson Bryan, Lori Tull

Non-FDA Participants: Elizabeth Smith, Jonathan Gaynor, James Whitmore, Helen 
Kim

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:
FDA informed Dendreon that the SPL dosage units were not yet in the system, but 
should be by next week.  FDA will notify Dendreon as soon as the units have been 
entered.  FDA recommended that the units be 50 million CD54+ cells in 250mL. 
 Dendreon asked if the antigen needed to be listed since it was considered an 
active ingredient.  FDA responded that a unit would not be needed for the 
protein.

FDA informed Dendreon that the SPL did not need to be ready before approval, but 
by the time of product distribution.  Dendreon noted that they were working to 
be able to implement the package insert within 24 hours of approval for 
physician training.  FDA responded that they thought this would not qualify as 
distribution of the product, so it would be acceptable.
FDA stated that they agreed with Dendron’s proposal for the CMC PMC submitted in 
amendment 49.  Regarding Dendreon’s request for a waiver for submission of lot 
distribution reports every six months, FDA stated that they would not grant this 
request because the information was needed for entry in the OBE database.  FDA 
did not feel that submission of these reports would be burdensome to Dendreon.

FDA asked if Dendreon had concerns regarding the label revisions communicated in 
today’s email.  Dendreon agreed to the revisions and committed to emailing a 
final clean copy of the agreed upon label this afternoon and following with a 
submission to the BLA.
 