Cosela: how long were the pivotal tox studies?

“day iv toxicity studies were considered the pivotal toxicity studies which cover the clinical dosing route and duration.”

“Additional oral toxicity studies in rats (up to 28-days) and dogs (up to 14-days) assessed longer term trilaciclib exposures and confirmed similar total drug exposure from repeated oral and iv dosing. Dose-limiting toxicity in the 14-day and 28-day studies was consistent with exaggerated pharmacology and generally similar to the 7-day iv toxicity study results.”

“Seven-day iv (30 min infusion) pilot toxicity in dogs with a two-week drug-free recovery phase.”