Seamless Oncology-Drug Development

N Engl J Med. 2016 May 26;374(21):2001-3. doi: 10.1056/NEJMp1603747. Epub 2016 Apr 13.

Authors

Tatiana M Prowell¹, Marc R Theoret¹, Richard Pazdur¹

Affiliation

¹ From the Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring (T.M.P., M.R.T., R.P.), and the Breast Cancer Program, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore (T.M.P.) - both in Maryland.

PMID: 27074059
DOI: 10.1056/NEJMp1603747

No abstract available

MeSH terms

Antibodies, Monoclonal, Humanized / therapeutic use*
Antineoplastic Agents / therapeutic use*
Clinical Trials as Topic / standards*
Drug Approval / organization & administration*
Drug Discovery
Humans
Neoplasms / drug therapy*
Therapeutic Human Experimentation
United States
United States Food and Drug Administration

Substances

Antibodies, Monoclonal, Humanized
Antineoplastic Agents
pembrolizumab