Tissue-Agnostic Drug Development: A New Path to Drug Approval.
| Autor: | Thein KZ; Division of Hematology & Medical Oncology, Oregon Health & Science University/Knight Cancer Institute, Portland, Oregon., Lemery SJ; Division of Oncology 3, Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food & Drug Administration, Silver Spring, Maryland., Kummar S; Division of Hematology & Medical Oncology, Oregon Health & Science University/Knight Cancer Institute, Portland, Oregon. kummar@ohsu.edu.; Center for Experimental Therapeutics, Division of Hematology & Medical Oncology, Knight Cancer Institute, Oregon Health & Science University, Portland, Oregon. |
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| Jazyk: | angličtina |
| Zdroj: | Cancer discovery [Cancer Discov] 2021 Sep; Vol. 11 (9), pp. 2139-2144. |
| DOI: | 10.1158/2159-8290.CD-21-0554 |
| Abstrakt: | In recent years, there has been remarkable progress in our understanding of cancer biology, host responses, and the concept of precision oncology. These advances have focused attention on biomarker-driven, tissue-agnostic drug development strategies. The recent approvals by the FDA of pembrolizumab for the treatment of unresectable or metastatic, microsatellite instability-high or deficient mismatch repair solid tumors, and more recently for the treatment of tumor mutational burden-high tumors; and of larotrectinib and entrectinib for the treatment of neurotrophic tyrosine kinase ( NTRK ) fusion-positive solid tumors, have further heightened interest in target-driven as opposed to histology-driven drug development. Herein, we focus on tissue-agnostic clinical drug development with an understanding of target modulation in the context of histology. The use of molecular genetics and biomarker-driven strategies rather than traditional histology based on organ of origin has reinforced the concept of tissue-agnostic drug development. Recent approvals in the United States, Europe, Japan, Australia, and other regions have further heightened interest in target-driven as opposed to histology-driven drug development. (©2021 American Association for Cancer Research.) |
| Databáze: | MEDLINE |
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