# Tumour-agnostic (tissue-agnostic) approval

Source: https://onco.cc/terms/tumour-agnostic/  
OnCo record `tumour-agnostic` (Term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A tumour-agnostic approval lets a drug be used for any cancer carrying a specific molecular feature, regardless of where it started.

## Summary

A tumour-agnostic, or tissue-agnostic, approval allows a drug to be used for any cancer carrying a specific molecular feature, regardless of the organ in which it started. Examples are Pembrolizumab for MSI-H disease in 2017 and TMB-high disease in 2020, larotrectinib, entrectinib and repotrectinib for NTRK fusions, Dabrafenib + trametinib for BRAF V600E, Selpercatinib for RET, and Trastuzumab deruxtecan for HER2 IHC 3+ tumours in 2024. Such approvals rest on basket trials and broad genomic testing, which is why DESTINY-PanTumor02 and DESTINY-CRC02 are linked. The term is referenced by the Non-small-cell lung cancer, Colorectal, Biliary tract, Endometrial and Cervical cancer entries and by the bottleneck on rare and paediatric cancers without markets.

## Fields

- Kind: Term
- Last checked: 2026-09-04

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Tissue-agnostic_drug
- Wikipedia: https://en.wikipedia.org/wiki/Tissue-agnostic_drug

## Connected records

- drugs: [Dabrafenib + trametinib](https://onco.cc/drugs/dabrafenib-trametinib/), [Entrectinib](https://onco.cc/drugs/entrectinib/), [Larotrectinib](https://onco.cc/drugs/larotrectinib/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/), [Selpercatinib](https://onco.cc/drugs/selpercatinib/), [Trastuzumab deruxtecan](https://onco.cc/drugs/trastuzumab-deruxtecan/)
- cancers: [Advanced and metastatic small bowel adenocarcinoma](https://onco.cc/cancers/advanced-small-bowel-adenocarcinoma/), [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Cancer of unknown primary (CUP)](https://onco.cc/cancers/cancer-of-unknown-primary/), [Cancer of unknown primary, unfavourable (adenocarcinoma and poorly differentiated carcinoma)](https://onco.cc/cancers/cup-unfavourable/), [Cervical cancer](https://onco.cc/cancers/cervical/), [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Endometrial cancer](https://onco.cc/cancers/endometrial/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/), [HER2-amplified colorectal cancer](https://onco.cc/cancers/her2-amplified-colorectal/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Microsatellite-unstable (MSI-high) gastric cancer](https://onco.cc/cancers/gastric-msi-high/), [Mismatch-repair deficient (MSI-high) colorectal cancer](https://onco.cc/cancers/msi-high-colorectal/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [NTRK fusion-positive non-small-cell lung cancer](https://onco.cc/cancers/ntrk-fusion-nsclc/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/), [Prostate cancer](https://onco.cc/cancers/prostate/), [Salivary gland cancers](https://onco.cc/cancers/salivary-gland/), [Secretory carcinoma of the breast](https://onco.cc/cancers/secretory-carcinoma-breast/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- trials: [DESTINY-CRC01](https://onco.cc/trials/destiny-crc01/), [DESTINY-CRC02](https://onco.cc/trials/destiny-crc02/), [DESTINY-PanTumor02](https://onco.cc/trials/destiny-pantumor02/), [DETERMINE](https://onco.cc/trials/determine-trial/), [DETERMINE arm 04: trastuzumab with pertuzumab in HER2-amplified or mutated rare cancers](https://onco.cc/trials/determine-arm04/), [KEYNOTE-158](https://onco.cc/trials/keynote-158/), [MyPathway](https://onco.cc/trials/mypathway/), [NCI-MATCH (EAY131)](https://onco.cc/trials/nci-match/), [ROAR (Rare Oncology Agnostic Research) basket: BRAF V600E biliary tract cancer cohort](https://onco.cc/trials/roar/), [TAPUR (Targeted Agent and Profiling Utilization Registry)](https://onco.cc/trials/tapur/)
- terms: [Basket trial](https://onco.cc/terms/basket-trial/), [Basket, umbrella, and platform trials](https://onco.cc/terms/basket-umbrella-platform/), [BRAF V600E mutation](https://onco.cc/terms/braf-v600-mutation/), [Driver mutation](https://onco.cc/terms/driver-mutation/), [HER2 and genomic testing for biliary cancer on the NHS](https://onco.cc/terms/genomic-testing-biliary-uk/), [Off-label](https://onco.cc/terms/off-label/), [Orphan drug](https://onco.cc/terms/orphan-drug/), [Pancreatic cancer drugs in England: NICE appraisals and the Cancer Drugs Fund (September 2026)](https://onco.cc/terms/pancreatic-cancer-uk-drug-access/), [Rare cancers](https://onco.cc/terms/rare-cancers/)
- key papers: [Detection of NRG1 gene fusions in solid tumors](https://onco.cc/key-papers/paper-jonna-nrg1-fusions-solid-tumours-ccr-2019/), [eNRGy: efficacy of zenocutuzumab in NRG1 fusion-positive cancer](https://onco.cc/key-papers/paper-enrgy-zenocutuzumab-nrg1-fusion-positive-cancer-nejm-2025/), [KEYNOTE-158: pembrolizumab in non-colorectal high microsatellite instability or mismatch repair-deficient cancer](https://onco.cc/key-papers/paper-keynote-158-pembrolizumab-msi-high-noncolorectal-jco-2020/), [KEYNOTE-177: pembrolizumab instead of chemotherapy as first treatment for mismatch-repair-deficient metastatic colorectal cancer](https://onco.cc/key-papers/paper-keynote-177-nejm-2020/), [Le 2015: PD-1 blockade works in tumours with mismatch-repair deficiency, whatever the organ](https://onco.cc/key-papers/paper-le-mmr-deficiency-pd1-nejm-2015/), [Le 2017: mismatch-repair deficiency predicts response to PD-1 blockade across twelve tumour types, leading to the first tissue-agnostic drug approval](https://onco.cc/key-papers/paper-le-mmr-deficiency-science-2017/), [Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142)](https://onco.cc/key-papers/paper-overman-checkmate-142-nivolumab-dmmr-colorectal-lancet-oncol-2017/), [Prevalence of microsatellite instability in prostate cancer and response to immune checkpoint blockade](https://onco.cc/key-papers/paper-abida-msi-prostate-checkpoint-blockade-jama-oncol-2019/), [Tumour response to TRK inhibition in a patient with pancreatic adenocarcinoma harbouring an NTRK gene fusion](https://onco.cc/key-papers/paper-oreilly-hechtman-ntrk-fusion-pancreatic-larotrectinib-ann-oncol-2019/)
- targets: [NTRK](https://onco.cc/targets/ntrk/), [RET](https://onco.cc/targets/ret/)
- bottlenecks: [Rare and paediatric cancers without markets](https://onco.cc/bottlenecks/b-rare-cancers/)
- ideas: [A fast route to the matched drug when it is licensed for another cancer](https://onco.cc/ideas/idea-bio1-mechanism-matched-access/), [A standard for tumour-agnostic approvals: minimum histologies and hierarchical modelling](https://onco.cc/ideas/idea-tr1-tumour-agnostic-approval-standard/), [A structured registry for every off-label cancer drug use](https://onco.cc/ideas/idea-data-off-label-outcomes-registry/), [Adopt tumour-agnostic cancer drug labels across regions by reliance, not re-review](https://onco.cc/ideas/idea-reg-tumour-agnostic-reliance/), [Combination baskets defined by resistance mechanism rather than by cancer type](https://onco.cc/ideas/idea-tr2-resistance-mechanism-baskets/), [Develop drugs in children first when the target is a children's target](https://onco.cc/ideas/idea-bio2-paediatric-first-development/), [Group trials by broken mechanism, not by organ or single mutation](https://onco.cc/ideas/idea-bio2-mechanism-defined-baskets/), [One standing umbrella trial for all rare cancers in a country](https://onco.cc/ideas/idea-bio2-rare-cancer-umbrella-platform/), [Reciprocal recognition of tumour-agnostic and rare-indication approvals across regulators](https://onco.cc/ideas/idea-moon-reciprocal-tumour-agnostic-approvals/), [Record what happens when doctors use cancer drugs off-label](https://onco.cc/ideas/idea-tr2-off-label-outcome-registry/), [WRN inhibitors: a second synthetic-lethal win for mismatch-repair cancers](https://onco.cc/ideas/idea-bio1-wrn-msi-programme/)
- collections: [Pancreatic Cancer Action Network (PanCAN)](https://onco.cc/collections/pancan/)
- institutions: [FDA Oncology Center of Excellence](https://onco.cc/institutions/fda-oce/), [Institut National du Cancer](https://onco.cc/institutions/inca/)
- pathways: [Mismatch repair & microsatellite instability](https://onco.cc/pathways/mismatch-repair-msi/)
- biomarkers: [BRAF V600E (and V600K)](https://onco.cc/biomarkers/braf-v600e/), [dMMR (mismatch repair deficiency by IHC)](https://onco.cc/biomarkers/dmmr-ihc/), [MSI-high (microsatellite instability by PCR or sequencing)](https://onco.cc/biomarkers/msi-high/), [NRG1 gene fusion](https://onco.cc/biomarkers/nrg1-fusion/), [NTRK1/2/3 gene fusion](https://onco.cc/biomarkers/ntrk-fusion/), [RET fusion and RET mutation](https://onco.cc/biomarkers/ret-fusion/), [TMB-high (tumour mutational burden >= 10 mutations per megabase)](https://onco.cc/biomarkers/tmb-high/)
- roadmaps: [Diagnostics roadmap: stains → gene panels → blood tests that decide treatment](https://onco.cc/roadmaps/diagnostics-roadmap/), [Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall](https://onco.cc/roadmaps/targeted-therapy-roadmap/), [Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on](https://onco.cc/roadmaps/trial-modernisation-roadmap/)

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JSON: https://onco.cc/api/v1/entities/tumour-agnostic.json