
 


Telecon Minutes - Provenge, January 5, 2007

 
Date: 1-5-07

Time: 15:30 EST

Sponsor: Dendreon

BLA 125197

Participants:

FDA: Drs. Ke Liu and Peter Bross
The sponsor: Dendreon

Telecon minutes

The sponsor called and discussed the following safety report to be filed at the 
end of January 2007.
  Sipeuleucel T treated subjects appeared to have a higher incidence of Stroke:
  Database used for the analyses: SAE reports; adverse event reports and 
  Cerebral vascular accident (CVA) events as well as death certificates.
  The analyses included the subjects from the following trials D9901 (127 
    patients)
    D9902A (98 patients)
    P-11 (176 patients)
    D9902B (approximately 200 patients) --- ongoing

  Overall, the CVA incidence for Sipeuleucel T and placebo in these trials were 
  4 % and 1.5%, respectively.

The sponsor stated that analyses will be performed to further investigate these 
events in relationship to other factors such as the concomitant medical 
conditions and medications.

For IND studies, the sponsor has the following plan as recommended by the 
independent date monitoring committee (IDMC):
  Expedited reporting of all CVA events, regardless of attribution
  Revising Informed Consent Form
  Revising the clinical protocols to include above information.

FDA stated that the sponsor needs to submit the analyses as soon as possible and 
the proposed plans for IND studies are reasonable.

End of conversation.
 

   