{"entity":{"id":"datopotamab-deruxtecan","kind":"drug","name":"Datopotamab deruxtecan","aka":[],"tldr":"Datopotamab deruxtecan (Datroway) is the second TROP2 ADC and shares Enhertu's payload. In 2026 it became a first-line option for triple-negative breast cancer patients who cannot receive immunotherapy.","summary":"Approved January 2025 for HR+/HER2- metastatic breast cancer after endocrine and chemotherapy (TROPION-Breast01) and June 2025 for EGFR-mutant NSCLC after TKI and chemotherapy (TROPION-Lung05). In Q2 2026 approved for first-line unresectable/metastatic TNBC in patients ineligible for PD-1/PD-L1 inhibitors based on TROPION-Breast02 (OS 23.7 vs 18.7 months per patient-facing summaries). Lower DAR than T-DXd; stomatitis and ocular surface events are characteristic; ILD occurs. TROPION-Breast05 tests it with durvalumab in PD-L1+ TNBC.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Datopotamab_deruxtecan","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Datopotamab%20deruxtecan"},{"label":"Datroway label (openFDA): TNBC indication and TROPION-Breast02 study section","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22DATROWAY%22"},{"label":"EMA Datroway product page (HR-positive indication only)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/datroway"}],"tags":[],"related":[],"cancers":["tnbc","breast-hr-positive","nsclc","tnbc-metastatic","egfr-mutant-nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":["trop2"],"drugs":[],"companies":["daiichi-sankyo","astrazeneca"],"institutions":[],"pathways":[],"terms":["ggfg"],"trials":["tropion-breast01","tropion-breast02","tropion-breast05","tropion-lung01","nct06350097","nct06564844","nct06417814","nct05215340","nct05555732","nct06357533","nct07291037","nct07098338","nct04644068","nct05061550","nct05489211","nct05687266","nct06130553","nct05417594","nct05460273","nct03742102","diamond","nct06112379"],"people":[],"bottlenecks":[],"keyPapers":["paper-tropion-breast01-china-cohort-esmo-open-2026"],"journals":[],"dependsOn":[],"notes":["Triple-negative breast cancer biomarkers: TROPION-Breast02 enrolled first-line patients not candidates for PD-1/PD-L1 inhibitors, in practice PD-L1-negative by CPS or IC score or otherwise ineligible, with no TROP2 requirement; TROPION-Breast05 pairs it with durvalumab in PD-L1-positive disease.","Triple-negative breast cancer, UK and EU status: the US indication (first-line, PD-1 or PD-L1 inhibitor ineligible; Datroway label effective 27 May 2026) has no EU counterpart yet, and in England the NICE appraisal for untreated triple-negative disease (GID-TA11535) and the appraisal for residual disease after neoadjuvant treatment (GID-TA11835, TROPION-Breast03) are both awaiting development. TROPION-Breast02 recruited at nine UK sites (Bristol, Cardiff, Edinburgh, three in London, Northampton, Nottingham and Warwick)."],"brand":"Datroway","code":"Dato-DXd, DS-1062","modality":"ADC","payload":"DXd (TOP1 inhibitor), DAR ~4","linker":"Tetrapeptide GGFG, cleavable","mechanism":"Humanised anti-TROP2 IgG1 with DXd; internalisation, lysosomal release, TOP1 inhibition, bystander effect.","approvals":[{"region":"US","year":2025,"indication":"HR+/HER2- metastatic breast cancer after endocrine therapy and chemotherapy"},{"region":"US","year":2025,"indication":"EGFR-mutant NSCLC after EGFR TKI and platinum chemotherapy"},{"region":"US","year":2026,"indication":"First-line unresectable/metastatic TNBC, PD-1/PD-L1 inhibitor ineligible"},{"region":"EU","year":2025,"indication":"HR+/HER2- mBC after endocrine + chemo; 4 Apr 2025"},{"region":"EU","year":2025,"indication":"HR-positive, HER2-negative unresectable or metastatic breast cancer after endocrine therapy and at least one line of chemotherapy; marketing authorisation issued 4 April 2025. No triple-negative indication in the EU on 24 September 2026","note":"https://www.ema.europa.eu/en/medicines/human/EPAR/datroway"}],"mechanismSteps":["Antibody binds TROP2 on the tumour cell surface","Receptor-ADC complex is internalised by endocytosis","Trafficked to the lysosome; linker is cleaved or antibody degraded","DXd is released inside the cell","Topoisomerase-I is trapped on DNA; replication forks collapse into double-strand breaks","Tumour cell dies by apoptosis","Membrane-permeable payload diffuses to kill neighbouring antigen-negative cells (bystander effect)"],"dosing":{"route":"IV infusion","schedule":"6 mg/kg (maximum 540 mg for ≥90 kg) every 3 weeks","modifications":"Hold for grade ≥2 stomatitis or ocular events; permanently discontinue for grade ≥2 ILD","monitoring":"Oral care with steroid mouthwash prophylaxis; baseline and periodic eye examination; respiratory symptoms","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2950227c-6230-4ca4-a135-46e44d9424a0"},"toxicity":[{"event":"Stomatitis","anyGradePct":59,"grade3PlusPct":7,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2950227c-6230-4ca4-a135-46e44d9424a0","note":"TROPION-Breast01, n=360"},{"event":"Nausea","anyGradePct":56,"grade3PlusPct":1.4,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2950227c-6230-4ca4-a135-46e44d9424a0","note":"TROPION-Breast01, n=360"},{"event":"Fatigue","anyGradePct":44,"grade3PlusPct":4.2,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2950227c-6230-4ca4-a135-46e44d9424a0","note":"TROPION-Breast01, n=360"},{"event":"Alopecia","anyGradePct":38,"grade3PlusPct":0,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2950227c-6230-4ca4-a135-46e44d9424a0","note":"TROPION-Breast01, n=360"},{"event":"Constipation","anyGradePct":34,"grade3PlusPct":0.3,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2950227c-6230-4ca4-a135-46e44d9424a0","note":"TROPION-Breast01, n=360"},{"event":"Dry eye","anyGradePct":27,"grade3PlusPct":0.8,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2950227c-6230-4ca4-a135-46e44d9424a0","note":"TROPION-Breast01, n=360"},{"event":"Keratitis","anyGradePct":24,"grade3PlusPct":1.1,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2950227c-6230-4ca4-a135-46e44d9424a0","note":"TROPION-Breast01, n=360"},{"event":"Vomiting","anyGradePct":24,"grade3PlusPct":1.1,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2950227c-6230-4ca4-a135-46e44d9424a0","note":"TROPION-Breast01, n=360"},{"event":"Stomatitis (any grade)","anyGradePct":63,"source":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22DATROWAY%22","note":"Datroway label, pooled safety population of 1,365 patients"},{"event":"Nausea (any grade)","anyGradePct":51,"source":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22DATROWAY%22","note":"Datroway label, pooled safety population"}],"access":[{"country":"US","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","assistance":"https://www.datroway.com","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: appraisal in progress for HR+/HER2- breast cancer; not yet recommended (2026)","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2025-01-17","type":"approval","region":"US","note":"HR+/HER2- metastatic breast cancer after endocrine therapy and chemotherapy (TROPION-Breast01)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2025-03","type":"approval","region":"JP","note":"First approval worldwide for HR+/HER2- breast cancer (December 2024, Japan MHLW)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2025-06-23","type":"accelerated-approval","region":"US","note":"EGFR-mutant NSCLC after TKI and platinum chemotherapy (accelerated) The confirmatory requirement was still open 1.2 years later, when the FDA's table was read.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy."},{"date":"2026-05-22","type":"approval","region":"US","note":"First-line unresectable/metastatic TNBC, PD-1/PD-L1 inhibitor ineligible (TROPION-Breast02)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer"}]},"route":"/drugs/datopotamab-deruxtecan/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"},{"id":"egfr-mutant-nsclc","kind":"cancer","name":"EGFR-mutated non-small-cell lung cancer","route":"/cancers/egfr-mutant-nsclc/"},{"id":"her2-low-metastatic-breast-cancer","kind":"cancer","name":"HER2-low and HER2-ultralow metastatic breast cancer","route":"/cancers/her2-low-metastatic-breast-cancer/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"hr-positive-metastatic-post-cdk46","kind":"cancer","name":"HR-positive metastatic breast cancer after CDK4/6 inhibitors","route":"/cancers/hr-positive-metastatic-post-cdk46/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"tnbc-metastatic","kind":"cancer","name":"Metastatic triple-negative breast cancer","route":"/cancers/tnbc-metastatic/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"pdl1-high-nsclc","kind":"cancer","name":"PD-L1-high non-small-cell lung cancer without a driver mutation","route":"/cancers/pdl1-high-nsclc/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"},{"id":"trop2-pet","kind":"technology","name":"TROP2 PET","route":"/technologies/trop2-pet/"}],"target":[{"id":"trop2","kind":"target","name":"TROP2","route":"/targets/trop2/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"},{"id":"daiichi-sankyo","kind":"company","name":"Daiichi Sankyo","route":"/companies/daiichi-sankyo/"}],"term":[{"id":"dxd","kind":"term","name":"DXd","route":"/terms/dxd/"},{"id":"ild","kind":"term","name":"Interstitial lung disease (ILD) / pneumonitis","route":"/terms/ild/"},{"id":"adc-side-effects-breast","kind":"term","name":"Living with an antibody-drug conjugate: diarrhoea, blood counts, eyes and lungs","route":"/terms/adc-side-effects-breast/"},{"id":"tnbc-residual-disease-decision","kind":"term","name":"Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point","route":"/terms/tnbc-residual-disease-decision/"},{"id":"ggfg","kind":"term","name":"Tetrapeptide GGFG (maleimide-GGFG-aminomethyl)","route":"/terms/ggfg/"},{"id":"topoisomerase-i-payloads","kind":"term","name":"Topoisomerase-I inhibitor payloads","route":"/terms/topoisomerase-i-payloads/"}],"trial":[{"id":"nct06112379","kind":"trial","name":"A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer","route":"/trials/nct06112379/"},{"id":"nct06564844","kind":"trial","name":"A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following C","route":"/trials/nct06564844/"},{"id":"nct06822543","kind":"trial","name":"A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cance","route":"/trials/nct06822543/"},{"id":"nct06130553","kind":"trial","name":"A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors","route":"/trials/nct06130553/"},{"id":"nct05460273","kind":"trial","name":"A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02)","route":"/trials/nct05460273/"},{"id":"nct07535437","kind":"trial","name":"A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer","route":"/trials/nct07535437/"},{"id":"nct03742102","kind":"trial","name":"A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer","route":"/trials/nct03742102/"},{"id":"nct07098338","kind":"trial","name":"A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)","route":"/trials/nct07098338/"},{"id":"nct06508216","kind":"trial","name":"A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negat","route":"/trials/nct06508216/"},{"id":"nct06417814","kind":"trial","name":"A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participan","route":"/trials/nct06417814/"},{"id":"nct06176261","kind":"trial","name":"DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs","route":"/trials/nct06176261/"},{"id":"nct05555732","kind":"trial","name":"Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)","route":"/trials/nct05555732/"},{"id":"diamond","kind":"trial","name":"DIAMOND","route":"/trials/diamond/"},{"id":"nct05061550","kind":"trial","name":"Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer","route":"/trials/nct05061550/"},{"id":"nct05866432","kind":"trial","name":"Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases","route":"/trials/nct05866432/"},{"id":"nct07291037","kind":"trial","name":"Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Acti","route":"/trials/nct07291037/"},{"id":"nct06350097","kind":"trial","name":"Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell L","route":"/trials/nct06350097/"},{"id":"nct05687266","kind":"trial","name":"Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations","route":"/trials/nct05687266/"},{"id":"nct06357533","kind":"trial","name":"Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥","route":"/trials/nct06357533/"},{"id":"nct07069595","kind":"trial","name":"PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease","route":"/trials/nct07069595/"},{"id":"nct07825753","kind":"trial","name":"Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer","route":"/trials/nct07825753/"},{"id":"nct04644068","kind":"trial","name":"Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies","route":"/trials/nct04644068/"},{"id":"nct05417594","kind":"trial","name":"Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies","route":"/trials/nct05417594/"},{"id":"nct05489211","kind":"trial","name":"Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)","route":"/trials/nct05489211/"},{"id":"nct05215340","kind":"trial","name":"Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionab","route":"/trials/nct05215340/"},{"id":"tropion-breast01","kind":"trial","name":"TROPION-Breast01","route":"/trials/tropion-breast01/"},{"id":"tropion-breast02","kind":"trial","name":"TROPION-Breast02","route":"/trials/tropion-breast02/"},{"id":"tropion-breast03","kind":"trial","name":"TROPION-Breast03","route":"/trials/tropion-breast03/"},{"id":"tropion-breast05","kind":"trial","name":"TROPION-Breast05","route":"/trials/tropion-breast05/"},{"id":"tropion-lung01","kind":"trial","name":"TROPION-Lung01","route":"/trials/tropion-lung01/"},{"id":"tropion-lung05","kind":"trial","name":"TROPION-Lung05","route":"/trials/tropion-lung05/"}],"paper":[{"id":"paper-tropion-breast02-ann-oncol-2026","kind":"paper","name":"Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial","route":"/key-papers/paper-tropion-breast02-ann-oncol-2026/"},{"id":"paper-tropion-breast01-china-cohort-esmo-open-2026","kind":"paper","name":"TROPION-Breast01 China cohort: datopotamab deruxtecan versus chemotherapy in previously treated HR-positive, HER2-negative breast cancer","route":"/key-papers/paper-tropion-breast01-china-cohort-esmo-open-2026/"},{"id":"paper-tropion-breast01-jco-2024","kind":"paper","name":"TROPION-Breast01: datopotamab deruxtecan versus chemotherapy in pretreated hormone-receptor-positive breast cancer, and why a PFS win did not translate to survival","route":"/key-papers/paper-tropion-breast01-jco-2024/"}],"roadmap":[{"id":"adc-generations","kind":"roadmap","name":"ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs","route":"/roadmaps/adc-generations/"},{"id":"tnbc-roadmap","kind":"roadmap","name":"Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the 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Roussy","route":"/institutions/gustave-roussy/"},{"id":"ncc-japan","kind":"institution","name":"National Cancer Center Hospital","route":"/institutions/ncc-japan/"}],"pairing":[{"id":"ild-overlap-caution","kind":"pairing","name":"Caution: DXd ADC + agents with pneumonitis risk","route":"/pairings/ild-overlap-caution/"},{"id":"adc-after-adc-caution","kind":"pairing","name":"Caution: TOP1 ADC immediately after TOP1 ADC","route":"/pairings/adc-after-adc-caution/"},{"id":"tki-then-adc-lung","kind":"pairing","name":"EGFR TKI → ADC on progression","route":"/pairings/tki-then-adc-lung/"},{"id":"trop2-pet-to-adc","kind":"pairing","name":"TROP2 PET → TROP2 ADC selection","route":"/pairings/trop2-pet-to-adc/"}],"person":[{"id":"aditya-bardia","kind":"person","name":"Aditya Bardia","route":"/people/aditya-bardia/"},{"id":"benjamin-besse","kind":"person","name":"Benjamin Besse","route":"/people/benjamin-besse/"},{"id":"sohn-joohyuk","kind":"person","name":"Joohyuk 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Tolaney","route":"/people/sara-tolaney/"},{"id":"lee-se-hoon","kind":"person","name":"Se-Hoon Lee","route":"/people/lee-se-hoon/"}],"bottleneck":[{"id":"b-incentive-misalignment","kind":"bottleneck","name":"Incentives reward me-too drugs and marginal gains","route":"/bottlenecks/b-incentive-misalignment/"}],"pathway":[{"id":"breast-cancer-signalling","kind":"pathway","name":"Breast cancer (KEGG map)","route":"/pathways/breast-cancer-signalling/"},{"id":"drug-efflux-pumps","kind":"pathway","name":"Drug efflux pumps (ABC transporters)","route":"/pathways/drug-efflux-pumps/"}],"biomarker":[{"id":"trop2-expression","kind":"biomarker","name":"TROP2 expression","route":"/biomarkers/trop2-expression/"}]}}