Orserdu: which risks did reviewers probe?

“Histopathology changes in rats and monkeys, other than those of the male and female reproductive organs (discussed below under fertility studies), were generally observations of increase in macrophage and/or neutrophilic infiltrates in mesenteric lymph node, lung, small and large intestines”

“Following a single oral administration of elacestrant in rats, radiolabeled elacestrant was detected in the majority of tissues, including ocular melanin containing tissues (eye uveal tract of Long Evans rats), but not in the brain, eye lens, spinal cord, and testes”

“(reduced body weight gain, low food consumption, red vulvar discharge) and embryo-fetal mortality (increased resorptions, post-implantation loss, and reduced number of live fetuses) were noted at ≥3 mg/kg/day (approximately 0.1 times the human AUC at the recommended dose).”