Population pharmacokinetic analysis of entrectinib in pediatric and adult patients with advanced/metastatic solid tumors: support of new drug application submission.

Mario González-SalesNassim DjebliGeorgina Meneses-LorenteVincent BuchheitGuillaume BonnefoisPierre-Olivier TremblayNicolas FreyFrançois Mercier

Published in: Cancer chemotherapy and pharmacology (2021)

A robust population PK model was built and qualified for entrectinib and M5, describing linear PK for both entities. This model was used to support the ROZLYTREK® new drug application.

Keyphrases

squamous cell carcinoma
small cell lung cancer
adverse drug
emergency department