Time: 15:30 EST
FDA: Drs. Ke Liu and Peter Bross
The sponsor: Dendreon
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.