tissue-agnostic approval
Regulatory authorization for cancer therapeutics based on specific biomarkers regardless of tumor anatomical origin or histological type.
Full Definition
Tissue-agnostic approval represents a paradigm shift in cancer drug regulation, where therapeutic agents receive approval for treatment of cancers harboring specific molecular alterations regardless of the tumor's tissue of origin or histological subtype. This approach reflects the precision oncology principle that molecular characteristics often determine treatment response more accurately than anatomical location. Notable examples include pembrolizumab for MSI-high tumors and larotrectinib for NTRK fusion-positive cancers. Tissue-agnostic approvals require robust evidence that the target biomarker drives oncogenesis across multiple cancer types and that the therapeutic benefit is consistent regardless of tumor origin. These approvals facilitate access to effective treatments for patients with rare molecular subtypes.
Usage
Usage note: Capitalize 'FDA' and specify the biomarker when discussing specific approvals.
In Context
- "The FDA granted tissue-agnostic approval for the NTRK inhibitor based on response rates across diverse tumor types." — regulatory affairs document
- "Tissue-agnostic approvals exemplify precision oncology's shift toward molecular rather than anatomical classification." — pharmaceutical policy analysis