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.”

“No evidence of mutagenic activity was observed when trastuzumab was tested in the standard Ames bacterial and human peripheral blood lymphocyte mutagenicity assays at concentrations of up to 5000 mcg/mL.”

“No evidence of mutagenic activity was observed when trastuzumab was tested in the standard Ames bacterial and human peripheral blood lymphocyte mutagenicity assays at concentrations of up to 5000 mcg/mL.”

“In an in vivo micronucleus assay, no evidence of chromosomal damage to mouse bone marrow cells was observed following bolus intravenous doses of up to 118 mg/kg of trastuzumab.”

“Herceptin has not been tested for carcinogenic potential.”

“Herceptin has not been tested for carcinogenic potential.”

“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.”