Balversa: which tox species, and why?

“Repeat Dose Toxicology Studies: The Applicant conducted oral repeat-dose general toxicology studies (up to 13 weeks) of erdafitinib in rats and dogs.”

“Rats and dogs were selected as relevant species for the pivotal 1- and 3-month repeat-dose toxicology studies since erdafitinib was shown to be pharmacologically active in both animal species.”

“Repeat Dose Toxicology Studies: The Applicant conducted oral repeat-dose general toxicology studies (up to 13 weeks) of erdafitinib in rats and dogs.”

“Repeat Dose Toxicology Studies: The Applicant conducted oral repeat-dose general toxicology studies (up to 13 weeks) of erdafitinib in rats and dogs.”

“The reproductive and developmental toxicity of erdafitinib was investigated in a non-GLP pilot study and a GLP pivotal embryo-foetal toxicity study in Sprague-Dawley rats. In accordance with ICHS9 and ICHS5 (R3) guidelines no studies on fertility and early development and on pre- and postnatal development have been performed.”

“In accordance with ICH S9 guideline, carcinogenicity studies are not warranted to support marketing for therapeutics intended to treat patients with advanced cancer.”

“Repeat Dose Toxicology Studies: The Applicant conducted oral repeat-dose general toxicology studies (up to 13 weeks) of erdafitinib in rats and dogs.”