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Besponsa: animal efficacy model or human cells?

inotuzumab ozogamicin · CD22
Efficacy evidence
Subcutaneous xenograft and systemically disseminated ALL mouse models
“The in vivo antitumor activity of inotuzumab ozogamicin was evaluated in xenograft and systemically disseminated ALL mouse models.”
✓ VerifiedFDA multi-discipline review, p. 33Source ↗
Why that model
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.
Reviewer's view of the efficacy data
FDA: nonclinical pharmacology and toxicology data adequate to support approval
“The nonclinical pharmacology and toxicology data submitted to this BLA are adequate to support the approval of inotuzumab ozogamicin for the proposed indication.”
✓ VerifiedFDA multi-discipline review, p. 36Source ↗

Same question, other ADCs

Adcetris

brentuximab vedotin · CD30
Three xenograft models from human HL and ALCL cell lines

Datroway

datopotamab deruxtecan · Trop-2
Nude mouse xenografts of human pancreatic cancer, NSCLC and breast cancer

Decnupaz

pivekimab sunirine · CD123
Two BPDCN patient-derived xenograft (PDX) models in NSG mice

Elahere

mirvetuximab soravtansine · FRα
Ovarian cancer xenograft mouse models (single IV dose)

Emrelis

telisotuzumab vedotin · c-Met
c-Met-positive NSCLC cell line-derived and patient-derived xenograft mouse models

Enhertu

fam-trastuzumab deruxtecan · HER2
HER2-positive breast cancer xenograft mouse models (e.g., KPL-4 in nude mice)

Kadcyla

ado-trastuzumab emtansine · HER2
HER2+ xenografts (BT-474 EI, Calu-3) and MMTV-HER2 transgenic tumor model; growth inhibition in all three at 3 to 31 mg/kg

Mylotarg

gemtuzumab ozogamicin · CD33
CD33+ HL-60 leukemia xenograft in mice: >80% tumor growth inhibition

Padcev

enfortumab vedotin · Nectin-4
Nectin-4-expressing patient-derived bladder cancer xenografts (AG-B1, AG-B8) in mice: >75% tumor growth inhibition

Polivy

polatuzumab vedotin · CD79b
Human DLBCL and B-cell lymphoma xenografts in mice; in vitro Ramos cytotoxicity

Tivdak

tisotumab vedotin · Tissue factor
Cervical cancer patient-derived xenograft (PDX) models in mice

Trodelvy

sacituzumab govitecan · Trop-2
Mouse xenografts bearing human Trop-2-expressing tumours

Zynlonta

loncastuximab tesirine · CD19
CD19-positive human Burkitt lymphoma (Ramos, Daudi) and DLBCL (WSU-DLCL2) xenografts in immunodeficient mice

Summary across all 14 ADCs →