Cokey Nguyen, Ph.D.

New Capabilities

Managing unexpected FDA reversal and planning Type A meeting strategy

The FDA rejected tabelecleucel for the second time on January 9, 2026—one day before its scheduled approval decision. The agency reversed its position after five years of dialogue, now claiming the previously accepted ALLELE trial no longer provides sufficient evidence of efficacy due to problems with study design, conduct, and analysis. The companies resolved all manufacturing issues and the FDA raised no safety concerns, but regulators demanded a new study for the first therapy targeting EBV+ post-transplant lymphoproliferative disease.

Updated Jan 13