Expert oncologists Dr. Jeffrey Zonder and Dr. Shaji Kumar discuss AL amyloidosis background, typical patient profiles, and disease staging and risk stratification.
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.