Model-Informed Drug Development Approach to Expedite Approval: Case of Alectinib in First-Line Anaplastic Lymphoma Kinase + Non-Small Cell Lung Cancer

Clin Pharmacol Ther. 2019 Apr;105(4):826-828. doi: 10.1002/cpt.1340. Epub 2019 Feb 5.

Authors

Peter N Morcos¹, Jiang Liu², Gideon M Blumenthal³, Hong Zhao²

Affiliations

¹ Clinical Pharmacology, Pharmaceutical Sciences, Pharma Research and Early Development (pRED), Roche Innovation Center, New York, New York, USA.
² Office of Clinical Pharmacology, Food and Drug Administration, Silver Spring, Maryland, USA.
³ Office of Hematology and Oncology Products, Food and Drug Administration, Silver Spring, Maryland, USA.

PMID: 30723888
DOI: 10.1002/cpt.1340

No abstract available

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Anaplastic Lymphoma Kinase / antagonists & inhibitors*
Carbazoles / therapeutic use*
Carcinoma, Non-Small-Cell Lung / drug therapy*
Carcinoma, Non-Small-Cell Lung / metabolism
Drug Approval / legislation & jurisprudence*
Drug Development / legislation & jurisprudence*
Humans
Lung Neoplasms / drug therapy*
Lung Neoplasms / metabolism
Piperidines / therapeutic use*
Protein Kinase Inhibitors / therapeutic use*
United States
United States Food and Drug Administration / legislation & jurisprudence

Substances

Carbazoles
Piperidines
Protein Kinase Inhibitors
Anaplastic Lymphoma Kinase
alectinib