Multi-organ mononuclear cell infiltration in rats and monkeys
“Pemigatinib induced multi-organ histologic mononuclear cell infiltration in both species.”
✓ VerifiedFDA multi-discipline review, p. 34Source ↗
Biodistribution & persistence
Wide rat tissue distribution, especially excretory, endocrine, alimentary and pigmented tissues; minimal CNS
“Following single oral administration, 14C-pemigatinib-derived radioactivity distributed widely to rat tissues especially excretory, endocrine, alimentary canal, and pigmented tissues, but only minimally in CNS tissues.”
✓ VerifiedFDA multi-discipline review, p. 34Source ↗
Modality-specific risk
On-target FGFR effects: hyperphosphatemia, mineralization, physeal dysplasia, bone and teeth toxicity
“Many of the pemigatinib-induced findings (e.g. hyperphosphatemia, mineralization, physeal dysplasia, and bone/teeth findings) were attributable to the primary pharmacology of FGFR inhibition.”
✓ VerifiedFDA multi-discipline review, p. 34Source ↗