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Breyanzi: how long were the pivotal tox studies?

lisocabtagene maraleucel · CD19 CAR-T
Longest pivotal study
14 weeks
“periods (0-100 days), in contrast with the control group (died by day 10-11).”
✓ VerifiedEMA assessment report, p. 34Source ↗
Pivotal GLP studies
None; traditional single/repeat-dose, genotox, carcinogenicity, DART and local tolerance studies not conducted
“In this light, traditional toxicity, including single and repeat-dose toxicity, genotoxicity, carcinogenicity, reproductive and developmental toxicity, and local tolerance studies were deemed of negligible utility and thus were not conducted.”
✓ VerifiedEMA assessment report, p. 36Source ↗
Route in tox
Intravenous (xenograft pharmacology)
“JCAR017 is an autologous cell-based product administered by intravenous infusion.”
✓ VerifiedEMA assessment report, p. 36Source ↗

Same question, other cell therapies

Abecma

idecabtagene vicleucel · BCMA CAR-T
12 weeks

Alofisel

darvadstrocel · Allogeneic adipose MSC
26 weeks

Amtagvi

lifileucel · TIL therapy
0 (no in vivo tox study)

Aucatzyl

obecabtagene autoleucel · CD19 CAR-T
2 weeks

Carvykti

ciltacabtagene autoleucel · BCMA CAR-T
14 weeks

ChondroCelect

characterised viable autologous cartilage cells · Autologous chondrocytes
53 weeks

Ebvallo

tabelecleucel · EBV-specific allogeneic T cells
20 weeks

Encelto

revakinagene taroretcel · CNTF (encapsulated RPE cell implant)
26 weeks

Gintuit

allogeneic cultured keratinocytes and fibroblasts in bovine collagen · Allogeneic keratinocytes + fibroblasts
52 weeks

Holoclar

autologous corneal epithelial cells containing limbal stem cells · Autologous limbal stem cells
0 (no in vivo tox study)

Kymriah

tisagenlecleucel · CD19 CAR-T
31 weeks

Lantidra

donislecel · Allogeneic pancreatic islets
0 (no in vivo tox study)

MACI

autologous cultured chondrocytes on porcine collagen membrane · Autologous chondrocytes
53 weeks

Omisirge

omidubicel · Expanded cord blood HPC
12 weeks

Provenge

sipuleucel-T · PAP-GM-CSF (autologous APC)
6 weeks

Rethymic

allogeneic processed thymus tissue · Allogeneic thymus tissue
39 weeks

Ryoncil

remestemcel-L · Allogeneic BM-MSC
26 weeks

Spherox

spheroids of autologous matrix-associated chondrocytes · Autologous chondrocyte spheroids
39 weeks

StrataGraft

allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen · Allogeneic keratinocytes + fibroblasts
20 weeks

Tecartus

brexucabtagene autoleucel · CD19 CAR-T
30 weeks

Tecelra

afamitresgene autoleucel · MAGE-A4 TCR-T
0 (no in vivo tox study)

Yescarta

axicabtagene ciloleucel · CD19 CAR-T
30 weeks

Zalmoxis

allogeneic T cells modified with HSV-TK / dLNGFR (nalotimagene carmaleucel) · HSV-TK suicide-gene T cells
3 weeks

Zemcelpro

dorocubicel · UM171-expanded cord blood CD34+
28 weeks

Laviv

azficel-T · Autologous fibroblasts
Not stated in public reviews

Tregzi

allogeneic Treg immunotherapy with HSPC and T cells (Orca-T) · Allogeneic Treg + HSPC + Tcon
Not stated in public reviews

Summary across all 27 cell therapies →