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Precedia/Cell therapy/Amtagvi/Skipped studies

Amtagvi: genotox, carcinogenicity and repro: done or skipped?

lifileucel · TIL therapy
Check my plan vs. these
Genotoxicity
Not conducted (not warranted given product characteristics and biological activity)
“No genotoxicity studies were conducted for AMTAGVI. Given the characteristics and biological activity of AMTAGVI, this omission is acceptable.”
✓ VerifiedFDA pharmacology/toxicology review, p. 14Source ↗
Carcinogenicity
Not conducted (expanded TILs free of tumor cells; residual tumor cell release controls; no clinical tumorigenicity signal)
“No tumorigenicity studies were conducted for AMTAGVI. This is acceptable since Studies #3 and #4 provided evidence that the expanded human TIL cultures in the studies were free of tumor cells.”
✓ VerifiedFDA pharmacology/toxicology review, p. 14Source ↗
Instead of carcinogenicity
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
Instead of genotoxicity
Not applicable: cells not genetically modified
“No genotoxicity studies were conducted for AMTAGVI. Given the characteristics and biological activity of AMTAGVI, this omission is acceptable.”
✓ VerifiedFDA pharmacology/toxicology review, p. 14Source ↗
DRG histopathology
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
Reproductive & developmental
Not conducted (product characteristics and biological activity)
“No DART studies were conducted for AMTAGVI. Given the characteristics and biological activity of AMTAGVI, this omission is acceptable.”
✓ VerifiedFDA pharmacology/toxicology review, p. 14Source ↗
Safety pharmacology
Not conducted; omission accepted
“No safety pharmacology studies were conducted for AMTAGV1. Given the characteristics and biological activity of AMTAGVI, this omission is acceptable.”
✓ VerifiedFDA pharmacology/toxicology review, p. 13Source ↗
Genotox: Ames
Not conducted (not warranted for this product)
“No genotoxicity, carcinogenicity, and developmental and reproductive toxicity (DART) studies were conducted for AMTAGVI. These studies are not warranted based on the product characteristics, biological activity, and safety profile.”
✓ VerifiedFDA pharmacology/toxicology review, p. 2Source ↗
Genotox: in vitro mammalian
Not conducted (not warranted for this product)
“No genotoxicity, carcinogenicity, and developmental and reproductive toxicity (DART) studies were conducted for AMTAGVI. These studies are not warranted based on the product characteristics, biological activity, and safety profile.”
✓ VerifiedFDA pharmacology/toxicology review, p. 2Source ↗
Genotox: in vivo
Not conducted (not warranted for this product)
“No genotoxicity, carcinogenicity, and developmental and reproductive toxicity (DART) studies were conducted for AMTAGVI. These studies are not warranted based on the product characteristics, biological activity, and safety profile.”
✓ VerifiedFDA pharmacology/toxicology review, p. 2Source ↗
Carcinogenicity model
Not conducted; TIL cultures shown tumor-cell free, release specs control residual tumor cells
“No tumorigenicity studies were conducted for AMTAGVI. This is acceptable since Studies #3 and #4 provided evidence that the expanded human TIL cultures in the studies were free of tumor cells.”
✓ VerifiedFDA pharmacology/toxicology review, p. 14Source ↗
Carcinogenicity timing
Not required (product characteristics, biological activity, safety profile)
“No genotoxicity, carcinogenicity, and developmental and reproductive toxicity (DART) studies were conducted for AMTAGVI. These studies are not warranted based on the product characteristics, biological activity, and safety profile.”
✓ VerifiedFDA pharmacology/toxicology review, p. 2Source ↗
hERG / QT
Not conducted (no safety pharmacology studies; omission accepted)
“No safety pharmacology studies were conducted for AMTAGV1. Given the characteristics and biological activity of AMTAGVI, this omission is acceptable.”
✓ VerifiedFDA pharmacology/toxicology review, p. 13Source ↗

Email me this as a cited memo

Skipped studies for Amtagvi, each with the regulator's own words, the page and a link. Ready to paste into a briefing document or send to your team.

Same question, other cell therapies

Abecma

idecabtagene vicleucel · BCMA CAR-T
Not conducted (traditional); insertion site analysis of 20 clinical lots

Alofisel

darvadstrocel · Allogeneic adipose MSC
Not conducted; cell-based product does not interact with DNA

Aucatzyl

obecabtagene autoleucel · CD19 CAR-T
Not conducted (third-generation SIN lentiviral vector, release criterion, long-term clinical monitoring for insertional mutagenesis)

Breyanzi

lisocabtagene maraleucel · CD19 CAR-T
Not conducted (traditional); lentiviral integration site mapping instead

Carvykti

ciltacabtagene autoleucel · BCMA CAR-T
Not conducted (classical); lentiviral integration site analysis instead

ChondroCelect

characterised viable autologous cartilage cells · Autologous chondrocytes
Not conducted (per cell-based product guideline)

Ebvallo

tabelecleucel · EBV-specific allogeneic T cells
Not conducted (ICH S6(R1)); non-genetically engineered cells

Encelto

revakinagene taroretcel · CNTF (encapsulated RPE cell implant)
Done: ISO-10993 battery (bacterial, mammalian cell, mouse micronucleus on device extracts), negative

Gintuit

allogeneic cultured keratinocytes and fibroblasts in bovine collagen · Allogeneic keratinocytes + fibroblasts
Not conducted (nature of product and clinical experience)

Holoclar

autologous corneal epithelial cells containing limbal stem cells · Autologous limbal stem cells
Not conducted (classical); in vitro karyotype analysis of cells

Kymriah

tisagenlecleucel · CD19 CAR-T
Not conducted (classical); lentiviral integration site analysis on 14 donor products

Lantidra

donislecel · Allogeneic pancreatic islets
Not conducted

Laviv

azficel-T · Autologous fibroblasts
Not conducted (autologous nature, prior human experience)

MACI

autologous cultured chondrocytes on porcine collagen membrane · Autologous chondrocytes
Not conducted on cells; four studies on collagen membrane were non-mutagenic

Omisirge

omidubicel · Expanded cord blood HPC
No standard genotox; cytogenetic/karyotype analyses of CF and NF showed no clonal aneuploidy

Provenge

sipuleucel-T · PAP-GM-CSF (autologous APC)
Not conducted (autologous nature of product)

Rethymic

allogeneic processed thymus tissue · Allogeneic thymus tissue
Not conducted

Ryoncil

remestemcel-L · Allogeneic BM-MSC
Not conducted (not warranted)

Spherox

spheroids of autologous matrix-associated chondrocytes · Autologous chondrocyte spheroids
Not conducted (per cell-based product guideline)

StrataGraft

allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen · Allogeneic keratinocytes + fibroblasts
Not conducted

Tecartus

brexucabtagene autoleucel · CD19 CAR-T
Not conducted (traditional); vector integration site analysis performed instead

Tecelra

afamitresgene autoleucel · MAGE-A4 TCR-T
Not conducted (no test models or relevant species); integration site analysis showed polyclonal products, no selective insertion

Tregzi

allogeneic Treg immunotherapy with HSPC and T cells (Orca-T) · Allogeneic Treg + HSPC + Tcon
Not conducted

Yescarta

axicabtagene ciloleucel · CD19 CAR-T
Not conducted; literature review of retroviral-transduced T-cell transformation risk instead

Zalmoxis

allogeneic T cells modified with HSV-TK / dLNGFR (nalotimagene carmaleucel) · HSV-TK suicide-gene T cells
Not conducted; in vitro retroviral integration site analysis instead

Zemcelpro

dorocubicel · UM171-expanded cord blood CD34+
Done for residual UM171 only (Ames, CHO micronucleus negative) plus cytogenetics of treated cells; none for cells

Summary across all 27 cell therapies →