Which nonclinical studies did approved multispecifics skip?

“Standard genotoxicity studies are not considered appropriate for this class of biological product, in line with the ICH S6 (R1) guideline.”

“Carcinogenicity studies have not been performed with MCLA-128 as they are not considered appropriate for this class of biological product, in line with the ICH S6 (R1) and ICH S9 guidelines.”

“Genotoxicity studies with elranatamab have not been conducted since they are generally not required for protein-based biotherapeutics per ICH S6(R1).”

“Carcinogenicity studies with elranatamab have not been conducted since they are generally not required for advanced cancer and protein-based biotherapeutics per ICH S9 and ICH S6(R1), respectively.”

“In accordance with the current ICH guidance (ICH S6(R1) 2011), genotoxicity studies have not been conducted with mosunetuzumab because the potential of biotechnology products, in particular high molecular weight monoclonal antibodies, to elicit DNA damage in somatic or germ cells via electrophilic reactions is unlikely.”

“No carcinogenicity studies have been conducted with mosunetuzumab and are not planned for the intended oncology indication, as per Guidance for Industry S6R1.”

“Thus, mutagenicity studies are considered inappropriate and were not conducted.”

“Thus, given the intended patient population and lack of mechanistic concern, carcinogenicity studies are not planned with zanidatamab (ICH S9)”