First FDA Approval Agnostic of Cancer Site - When a Biomarker Defines the Indication

N Engl J Med. 2017 Oct 12;377(15):1409-1412. doi: 10.1056/NEJMp1709968.

Authors

Steven Lemery¹, Patricia Keegan¹, Richard Pazdur¹

Affiliation

¹ From the Office of Hematology and Oncology Products (S.L., P.K.) and the Oncology Center of Excellence (R.P.), Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.

PMID: 29020592
DOI: 10.1056/NEJMp1709968

No abstract available

MeSH terms

Adult
Antibodies, Monoclonal, Humanized / therapeutic use*
Antineoplastic Agents / therapeutic use*
B7-H1 Antigen / metabolism
Biomarkers, Tumor*
Brain Neoplasms / drug therapy*
Breast Neoplasms / drug therapy
Child
Colorectal Neoplasms / drug therapy*
Colorectal Neoplasms / pathology
Digestive System Neoplasms / drug therapy*
Drug Approval*
Female
Humans
Male
Microsatellite Instability*
Neoplasm Metastasis / drug therapy
Neoplastic Syndromes, Hereditary / drug therapy*
Programmed Cell Death 1 Receptor / antagonists & inhibitors*
Programmed Cell Death 1 Receptor / metabolism
United States
United States Food and Drug Administration
Urogenital Neoplasms / drug therapy

Substances

Antibodies, Monoclonal, Humanized
Antineoplastic Agents
B7-H1 Antigen
Biomarkers, Tumor
CD274 protein, human
PDCD1 protein, human
Programmed Cell Death 1 Receptor
pembrolizumab

Supplementary concepts

Turcot syndrome