Inflammation and/or suppression in bone marrow, spleen, thymus and lymph nodes
“The effects in the hemolymphoid system included inflammation and/or suppressive effects in the bone marrow, spleen, thymus, or lymph nodes.”
✓ VerifiedFDA multi-discipline review, p. 38Source ↗
Biodistribution & persistence
Distribution to hair and eyes of pigmented rats; melanin binding
“Nonclinical ADME studies indicated distribution of radioactivity to hair and eyes of pigmented rats, thus alpelisib and/or its metabolites can bind melanin.”
✓ VerifiedFDA multi-discipline review, p. 38Source ↗
Modality-specific risk
On-target hyperglycemia and hyperinsulinemia with pancreatic endocrine changes
“Administration of alpelisib to rats and dogs increased blood insulin and glucose levels, which correlated with histopathologic changes in the pancreas (vacuolation or hyperplasia of endocrine cells).”
✓ VerifiedFDA multi-discipline review, p. 38Source ↗