“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 ↗