DEPARTMENT OF HEALTH AND HUMAN SERVICES
TELECONFERENCE MEMORANDUM Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research
Date\Time: March 23, 2007
CBER Representatives: Keith Wonnacott, Stephanie Simek, Celia Witten, Boguang Zhen, Peter Bross, Kimberly Benton, Mark Davidson, Tom Finn, Ashok Batra, Lori Tull
Sponsor’s Representative: Elizabeth Smith, Mark Frohlich, Lianng Yuh, Connie Spooner, Nicole Provost, David Urdal
STN : 125197/0
Subject: Weekly update telecon
There was discussion regarding Dendreon’s slides for presentation to the advisory committee. Dendreon will submit their slides to Gail today.
- Cerebrovascular events for all randomized studies with treatment arms as randomized (previously submitted; as reference)
- Cerebrovascular events for all randomized studies with treatment arms as exposed to treatment (cross-over/salvage patients included in treatment arm rather than placebo)
- Cerebrovascular events for all randomized studies with sipuleucel-T, salvage and placebo broken out separately
- Observed time to cerebrovascular events from last infusion for all randomized studies (data from D9902B/Study 3 now included)
- Overall survival by cumulative CD54 upregulation quartiles along with pure placebo (Integrated Studies 1 & 2)
- Overall survival in salvage treated patients by CD54 upregulation quartiles (Integrated Studies 1 & 2)
- CBER stated that there was one issue with regard to Dendreon’s response to the 483. CBER requested to see and review the data for six lots in module b(4) This data would be a major amendment to the BLA.
- Dendreon asked if CBER would be willing to discuss other scenarios.
- Validation for 3 lots in the facility then submit a supplement for increased capacity (b(4)), followed by an b(4)
- CBER responded that they would be willing to consider the limited capacity. CBER would discuss this internally and then schedule another telecom with Dendreon after the advisory committee to discuss the details. CBER would also discuss the supplement pathway internally.
- Dendreon agreed.