“Distribution of sunvozertinib-derived radioactivity in the uveal tract, meninges, and pigmented fur indicated melanin binding. Radioactivity in the brain and spinal cord remained below the limit of quantification, indicating that sunvozertinib has a low tendency to cross the blood-brain barrier.”
✓ VerifiedFDA multi-discipline review, p. 33Source ↗
Modality-specific risk
Embryo-fetal toxicity (labeled warning)
“Overall, given the nonclinical data, the pharmacology/toxicology team recommends a warning for embryo-fetal toxicity in the label for ZEGFROVY (sunvozertinib).”
✓ VerifiedFDA multi-discipline review, p. 35Source ↗