Gomekli: which risks did reviewers probe?

“findings correlated with histologic signs in the lymph nodes in the 3-month studies in rats and dogs, including minimal to moderate lymphoid hyperplasia, lymphoid depletion, and increases in plasma cells, as well as hypocellularity in rats.”

“For all tissues, the highest measured concentrations were observed within 4 hours and 0.5 hours post dose for the oral and IV routes, no specific retention was observed in melanin-containing tissues.”

“Overall, mirdametinib is considered as a selective developmental toxicant, and the clinical relevance of drug-induced embryofoetal lethality identified in rats and rabbits cannot be excluded.”