Ibtrozi: which risks did reviewers probe?

“Additional findings were noted in the thymus (atrophy), lymph nodes (erythrophagocytosis, foamy macrophages), and kidneys (basophilic casts, dilation, hyperplasia, vacuolation).”

“Taletrectinib was distributed throughout rat tissues. There was notable distribution of taletrectinib to melanin-containing tissues of the eyeball and skin. Taletrectinib also accumulated in the choroid plexus region of the brain indicating the drug can cross the blood brain barrier.”

“Because taletrectinib can cause fetal harm, the review team recommends an embryofetal toxicity warning.”

“Immunogenicity The Applicant’s Position: Not applicable. The FDA’s Assessment: Not applicable.”