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

“Consistent with the ICH S6 guidance, genetic toxicology studies were not conducted or required for dinutuximab.”

“Carcinogenicity studies were not required to support the licensing application for a product intended to treat advanced human cancer”

“In the repeat-dose toxicity studies, administration of dinutuximab in male and female rats resulted in no adverse effects on reproductive organs at exposures that were at least 60 fold higher than those observed clinically.”

“Increases in blood pressure and heart rate along with corresponding findings of shortened PR and QT intervals in ECG evaluations were noted, though QTc intervals were unaffected.”

“Consistent with the ICH S6 guidance, genetic toxicology studies were not conducted or required for dinutuximab.”

“Consistent with the ICH S6 guidance, genetic toxicology studies were not conducted or required for dinutuximab.”

“Consistent with the ICH S6 guidance, genetic toxicology studies were not conducted or required for dinutuximab.”

“Carcinogenicity studies were not required to support the licensing application for a product intended to treat advanced human cancer and are neither planned nor expected as post-marketing requirements at this time.”

“Carcinogenicity studies were not required to support the licensing application for a product intended to treat advanced human cancer and are neither planned nor expected as post-marketing requirements at this time.”

“In this study increases in heart rate were observed, consistent with tachycardia noted clinically, however, no clear changes in QTc, respiratory rate, or blood gas parameters were noted.”