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

“The in-vivo test was a mouse micronucleus assay involving single iv injection of trastuzumab at 29.5, 59 and 118 mg/kg. All tests gave clearly negative results.”

“Herceptin has not been tested for carcinogenic potential.”

“Reproductive function: No effects on menstrual cycles or sex hormone profiles Embryotoxicity: No maternal toxicity, embryotoxicity or teratogenicity Peri-/Post-natal toxicity: No maternal, foetal or neonatal toxicity”

“A study of the administration of trastuzumab together with Taxol, Adriamycin, or Cytoxan/Adriamycin in rhesus monkeys did not elicit significant findings on parameters like mortality and clinical observations, body weights, electrocardiograms, clinical pathology including hematology, serum chemistry and urinalysis.”