“Following oral administration of [14C]- vepdegestrant and whole-body autoradiography, the highest distribution of vepdegestrant in rats was in the liver, ovaries, kidneys, thyroid, spleen, and melanin-containing tissues (uveal tract, whole eye, and pigmented skin).”
✓ VerifiedFDA multi-discipline review, p. 48Source ↗
Modality-specific risk
Embryofetal toxicity (fetal harm based on animal findings and mechanism of action)
“Based on findings in animals and mechanism of action, vepdegestrant can cause fetal harm when administered to a pregnant woman.”
✓ VerifiedFDA multi-discipline review, p. 49Source ↗
Anti-drug antibodies: animals
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.
Anti-drug antibodies: patients
Not assessed in the pivotal trial
“No immunogenicity assessments were included in Study C4891001.”
✓ VerifiedFDA multi-discipline review, p. 179Source ↗