Koselugo: which risks did reviewers probe?

“Inflammatory and ulcerative GI tract findings associated with secondary changes in the liver and lymphoreticular system at free exposures approximately 19.5 times the clinical free AUC at the MRHD were observed in mice.”

“Relatively higher concentrations of radioactivity were found in the lung, liver, kidney and adrenal gland at each timepoint. There was no evidence of high affinity melanin-specific binding of radioactivity in the pigmented tissues (pigmented skin and uveal tract).”

“While ocular effects were not clear in the nonclinical toxicology studies in adult animals, ocular toxicity does occur clinically with selumetinb and other MEK inhibitors.”

“In SPRINT Phase II Stratum I data, the Pediatric pool and Adult monotherapy pool, there are no events suggestive immunogenicity or allergy to selumetinib (such as AEs of severe hypersensitivity).”