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

“Genetic toxicology studies were not conduct for ocrelizumab, consistent with ICH S6 guidance.”

“The sponsor submitted a carcinogenicity assessment waiver request under IND 100593 (Serial No. 0675, February 4, 2016). The waiver was granted”

“The results of this study demonstrate an effect on gestation length in dams and adverse effects of ocrelizumab on the neonate, including an increase in stillbirths and neonatal death, B-cell depletion, and microscopic changes in kidney and bone marrow.”

“Safety pharmacology endpoints were included in repeat dose studies in monkey.”

“Genetic toxicology studies were not conduct for ocrelizumab, consistent with ICH S6 guidance.”

“Genetic toxicology studies were not conduct for ocrelizumab, consistent with ICH S6 guidance.”

“Genetic toxicology studies were not conduct for ocrelizumab, consistent with ICH S6 guidance.”

“Assessment of carcinogenic potential was deemed not feasible and the sponsor’s waiver request was granted.”

“Assessment of carcinogenic potential was deemed not feasible and the sponsor’s waiver request was granted.”

“No treatment related observations in either respiratory, cardiovascular or CNS observations were noted following doses of up to 100 mg/kg ocrelizumab.”