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Atlas/Bispecific antibodies/Elrexfio/Skipped studies

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

elranatamab · BCMA x CD3
Check my plan vs. these
Genotoxicity
Not conducted (ICH S6(R1))
“Genotoxicity studies with elranatamab have not been conducted since they are generally not required for protein-based biotherapeutics per ICH S6(R1).”
✓ VerifiedEMA assessment report, p. 43Source ↗
Carcinogenicity
Not conducted (ICH S9 / S6(R1))
“Carcinogenicity studies with elranatamab have not been conducted since they are generally not required for advanced cancer and protein-based biotherapeutics per ICH S9 and ICH S6(R1), respectively.”
✓ VerifiedEMA assessment report, p. 43Source ↗
Reproductive & developmental
Not conducted (weight-of-evidence); reproductive organs assessed in 3-month monkey study, no effects
“Embryofetal developmental toxicity was evaluated using a weight of evidence (WOE) risk assessment”
✓ VerifiedFDA multi-discipline review, p. 48Source ↗
Safety pharmacology
Incorporated into repeat-dose monkey studies (ECG, heart rate; respiratory/CNS by clinical observation)
“No safety pharmacology studies were conducted. Safety pharmacology was evaluated as part of the general toxicology studies performed with elranatamab.”
✓ VerifiedFDA multi-discipline review, p. 53Source ↗

Same question, other bispecifics

Bizengri

zenocutuzumab · HER2 x HER3
Not conducted (ICH S6(R1))

Blincyto

blinatumomab · CD19 x CD3
Not conducted (ICH S6(R1); protein of natural amino acids)

Columvi

glofitamab · CD20 x CD3
Not conducted (ICH S6(R1))

Epkinly

epcoritamab · CD20 x CD3
Not conducted (ICH S6(R1), ICH S9)

Hemlibra

emicizumab · FIXa x FX
Not conducted (ICH S6)

Imdelltra

tarlatamab · DLL3 x CD3
Not conducted (ICH S6(R1))

Kimmtrak

tebentafusp · CD3 x gp100 (TCR fusion)
Not conducted (fusion protein; ICH S6/S9)

Korjuny

catumaxomab · EpCAM x CD3
Not conducted (ICH S6(R1))

Lunsumio

mosunetuzumab · CD20 x CD3
Not conducted (ICH S6(R1))

Lynozyfic

linvoseltamab · BCMA x CD3
Not conducted (antibody not expected to interact with DNA)

Ordspono

odronextamab · CD20 x CD3
Not conducted (antibody not expected to interact with DNA)

Removab

catumaxomab · EpCAM x CD3
Not conducted (not submitted; biologic, no relevant model)

Rybrevant

amivantamab · EGFR x MET
Not conducted (not appropriate for antibodies)

Talvey

talquetamab · GPRC5D x CD3
Not conducted (ICH S6; biotechnology-derived product)

Tecvayli

teclistamab · BCMA x CD3
Not conducted (ICH S6(R1))

Vabysmo

faricimab · VEGF-A x Ang-2
Not conducted (ICH S6(R1))

Ziihera

zanidatamab · HER2 x HER2 (biparatopic)
Not conducted (ICH S6(R1), ICH S9)

Summary across all 18 bispecifics →