Record of Telephone Conversation - Provenge, March 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-Mar-2010 04:00 AM        Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):
1. Information Request

Author: LORI TULL

Telecon Summary:
discussion regarding expanding indication

FDA Participants: Peter Bross, Wilson Bryan, Chaohong Fan, Bindu George, Lori Tull

Non-FDA Participants: Elizabeth Smith, Mark Frolich, Helen Kim

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

FDA requested clarification regarding Amd # 42 especially interpretation of Table 2 and pg 8 guidelines for prevention and treatment of rigors.  

Dendreon responded that they preformed an exploratory analysis of effect of time to infusion on survival and there was not a significant interaction however there was a slight suggestion that longer time to infusion may be associated with shorter survival times although no definitive conclusions can be reached.

Dendreon clarified that the guidelines for prevention and treatment of rigors were used in clinical trials and that all patients were premedicated with acetamenophen and diphenhydramine.

1. FDA requested clarification regarding Dendreon’s current thinking regarding feasibility and design of a study to demonstrate clinical benefit in ---b(4)---------------------------------

2. Dendreon responded that they could consider doing a study of --b(4)---------- patients in Europe but that they had planned to do a study in ----b(4)-----------------------------------------------------------------------------------------------------------

   FDA will submit a redline version of label changes discussed Friday