RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125197/0 Office: OCTGT
Telecon Date/Time: 04-Mar-2010 11:00 AM Initiated by FDA? Yes
Author: LORI TULL
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
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.