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

“Genotoxicity studies have not been performed according to ICH S6(R1).”

“Standard carcinogenicity studies are generally inappropriate for biotechnology-derived pharmaceuticals according to ICH S6.”

“Studies to investigate reproductive and developmental toxicity have not been performed due to the lack of an appropriate animal species, the intended patient population with late-stage malignant disease.”

“Due to the restricted specificity of catumaxomab for human target antigens, safety aspects were assessed in vivo using the surrogate antibody BiLu in a secondary PD study and as part of a toxicology study (see Toxicology section).”