Open AccessTumor-Agnostic Drug Development
Author(s) -
Michael Offin,
Dazhi Liu,
Alexander Drilon
Publication year - 2018
Publication title -
american society of clinical oncology educational book/educational book
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.463
H-Index - 35
eISSN - 1548-8756
pISSN - 1548-8748
DOI - 10.1200/edbk_200831
Subject(s) - drug development , drug , clinical trial , medicine , identification (biology) , drug approval , computational biology , pharmacology , biology , botany
Therapies designed to target cancers that harbor specific molecular signatures have reshaped the landscape of oncologic drug development, and advances in next generation sequencing have led to an increase in the identification of these alterations across tumor types. Tumor-agnostic trial designs, such as the "basket trial," have been developed as an approach to study the efficacy of these treatments and increase patient access, especially for patients whose tumors carry these alterations infrequently. We review key aspects of these genomically enriched trial strategies and their impact on drug development and approval.