In July, the trial was put on a clinical hold at the direction of the Food and Drug Administration. At that time, the company revealed three patient deaths, also the result of cerebral edema. According to Bishop, investigators pinpointed the likely culprit as the addition of fludarabine to the pre-conditioning regimen. Fludarabine is a chemotherapy drug used here as a one-time primer for treatment, used in an effort to increase the effectiveness of the experimental therapy.
- December 11, 2016
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