Human lymphoma cell line-derived xenograft (CDX) mouse models and one patient-derived xenograft (PDX) model
“The in vivo antitumor activity of epcoritamab was evaluated in various human lymphoma cell line-derived xenograft (CDX) mouse models and in one patient-derived xenograft (PDX) mouse model.”
✓ VerifiedFDA multi-discipline review, p. 44Source ↗
Why that model
Epcoritamab does not bind dog, pig, rat or mouse CD20
“Epcoritamab bound a cell line transfected with rabbit CD20 (KD=6.93 nM), but did not bind cells expressing dog, pig, rat, or mouse CD20 under the conditions tested.”
✓ VerifiedFDA multi-discipline review, p. 43Source ↗
Reviewer's view of the efficacy data
FDA: antitumor activity in prophylactic, established and late-treatment settings, but relative activity could not be established due to varied study designs
“Antitumor activity was observed in each of the prophylactic, established, and late treatment settings, but the relative antitumor activities could not be established due to the varied study designs and treatments.”
✓ VerifiedFDA multi-discipline review, p. 44Source ↗