SurVaxM missed the SURVIVE trial OS end point in newly diagnosed glioblastoma, whereas a subgroup of patients 65 or younger had significantly improved OS.
The resubmission follows a third complete response letter issued in July 2026 that cited manufacturing deficiencies rather than efficacy or safety concerns.
The FDA set a PDUFA target action date of March 31, 2027, for tabelecleucel in relapsed or refractory EBV-positive post-transplant lymphoproliferative disease.