No dedicated immunotoxicity studies; TDAR effects in rats judged non-adverse as immune responses were still mounted
“Imlunestrant affected T-cell dependent antibody responses across studies but because animals mounted anti-KLH IgM and IgG responses it was concluded that effects on seroconversion did not functionally suppress the immune response and were considered non-adverse.”
On-target male and female reproductive organ toxicity; also hematopoietic/lymphatic, kidney, urinary bladder and eye findings
“The major target organs of toxicity in the general rat and monkey toxicology studies were male and female reproductive organs, hematopoietic/lymphatic system, kidney, urinary bladder, and eye and were generally consistent across the short and long-term studies.”
✓ VerifiedFDA multi-discipline review, p. 41Source ↗