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

“A standard Ames test was negative. A full genotoxicity test battery and carcinogenicity evaluation have not been conducted for omalizumab, due to the absence of a relevant species appropriate for such studies.”

“No carcinogenicity study with omalizumab was performed since omalizumab does not bind rodent IgE.”

“at doses of 0, 3, 15 and 75 mg/kg once daily on Days 20-22, and then once weekly through Day 50 did not elicit maternal toxicity, embryotoxicity or teratogenicity.”

“Safety parameters were monitored at regular intervals in the 4-week and 6-month monkey toxicology studies. These parameters included vital functions such as blood pressure, electrocardiograph measurements, heart rate and respiration rate.”

“A standard Ames test was negative.”

“A full genotoxicity test battery and carcinogenicity evaluation have not been conducted for omalizumab, due to the absence of a relevant species appropriate for such studies.”

“A full genotoxicity test battery and carcinogenicity evaluation have not been conducted for omalizumab, due to the absence of a relevant species appropriate for such studies.”

“No carcinogenicity study with omalizumab was performed since omalizumab does not bind rodent IgE.”

“No carcinogenicity study with omalizumab was performed since omalizumab does not bind rodent IgE.”

“Safety parameters were monitored at regular intervals in the 4-week and 6-month monkey toxicology studies. These parameters included vital functions such as blood pressure, electrocardiograph measurements, heart rate and respiration rate. No drug-related effects were observed for any of these endpoints.”