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 ↗