Brukinsa: how long were the pivotal tox studies?

“In the 39-week study in dogs, zanubrutinib was administered orally at doses of 10, 30, or 100 mg/kg/day with a 4-week recovery period.”

“Zanubrutinib was administered once daily to rats and dogs in studies up to 6 months in rats and 9 months in dogs. The studies were conducted using the oral route of administration, which is consistent with the intended clinical route of administration.”

“The studies were conducted using the oral route of administration, which is consistent with the intended clinical route of administration.”