Truseltiq: genotox, carcinogenicity and repro: done or skipped?

“Infigratinib was not mutagenic in the bacterial reverse mutation test. Infigratinib was not clastogenic in an in vitro human peripheral blood lymphocyte chromosome aberration assay or an in vivo bone marrow micronucleus assay in rats.”

“Carcinogenicity studies are not recommended for the proposed indication.”

“Increases in embryo‐fetal death, with corresponding reductions in the numbers of viable fetuses, were observed at 10 mg/kg/day, and reductions in mean fetal body weights were observed at 3 and 10 mg/kg/day. Fetal abnormalities were observed at increased incidences at all doses.”

“Infigratinib had no toxicologically significant effects on cardiovascular function in telemetered dogs or on neurobehavioral and respiratory functions in rats.”

“Infigratinib was not mutagenic in the bacterial reverse mutation test.”

“Infigratinib was not clastogenic in an in vitro human peripheral blood lymphocyte chromosome aberration assay or an in vivo bone marrow micronucleus assay in rats.”

“Infigratinib was not clastogenic in an in vitro human peripheral blood lymphocyte chromosome aberration assay or an in vivo bone marrow micronucleus assay in rats.”

“Carcinogenicity studies are not recommended for the proposed indication.”

“Carcinogenicity studies are not warranted to support a marketing application for the proposed indication.”

“Infigratinib and the metabolites BHS697 and CQM157 inhibited hERG current but at concentrations that were much higher than peak exposure of each in humans at the recommended clinical dose of infigratinib (125 mg QD).”