Utilizing PK Characterisation & Exposure-Response Analysis to Support Dosing in Paediatric Populations
Time: 2:00 pm
day: Conference Day 1
Details:
- Population PK analysis indicated the pharmacokinetics of brentuximab vedotin (BV) were consistent in adult and pediatric patients
- BV ADC exposures were lower in patients aged 2 to <12 years vs. ≥12 years following body weight dosing
- Exposure-Response analyses and additional age/body weight subgroup analyses showed consistent benefit-risk profiles across age groups; these findings support the approve body weight dose for pediatric patients 2 years of age and older with previously untreated high risk classical Hodgkin lymphoma