Provenance Record

Excellent structure (Overview / What We Know with four sub-sections / What We Don't Know). Technical, precise, neutral. Length appropriate for News (844 words). Every clinical number cited to a source that actually contains it — no compound-citation issues. Strong Rule 9 discipline: PubMed papers cited directly for the underlying clinical data rather than press-release secondaries.

{"source-0":{"url":"https://oncodaily.com/oncolibrary/breast-oncology/fda-approves-t-dxd","snapshot":"source-0.html.gz","status":"OncoDaily FDA-approval coverage. Verifies May 15 approval, Stage II/III indication wording, IHC 3+/ISH+ test requirement, 5.4 mg/kg/3-week dosing schedule (4 + 14 cycles), 927 trial enrollment, boxed warning + neutropenia + LVD label warnings."},"source-1":{"url":"https://www.stocktitan.net/news/AZN/enhertu-fam-trastuzumab-deruxtecan-nxki-approved-in-the-us-for-two-6s694b50qmj5.html","snapshot":"source-1.html.gz","status":"AstraZeneca official press release (May 15). Verifies neoadjuvant + adjuvant approval wording verbatim, 'reduced risk of invasive disease recurrence or death (IDFS) by 53%' framing, 'no new safety concerns' AstraZeneca quote verbatim, 927-patient enrollment scope."},"source-2":{"url":"https://pubmed.ncbi.nlm.nih.gov/41370739/","snapshot":"source-2.html.gz","status":"PRIMARY publication (Rule 9): NEJM DESTINY-Breast05 paper, '2026 Feb 26;394(9):845-857. doi: 10.1056/NEJMoa2514661'. Verifies all DESTINY-Breast05 numerical specifics: 92.4%/83.7% 3-year IDFS, HR 0.47, CI 0.34-0.66, events 6.2% (51 pts) vs 12.5% (102 pts), ILD 9.6% vs 1.6% with two ILD deaths."},"source-3":{"url":"https://pubmed.ncbi.nlm.nih.gov/41130363/","snapshot":"source-3.html.gz","status":"PRIMARY publication (Rule 9): Annals of Oncology DESTINY-Breast11 paper. Verifies arm splits (286/321/320), pCR 43.0%/67.3%/56.3%, 11.2pp absolute difference + 95% CI 4.0-18.3 + P=0.003, EFS HR 0.56 (95% CI 0.26-1.17) at 4.5% maturity, T-DXd-alone arm closed early per IDMC recommendation."},"source-4":{"url":"https://www.mychesco.com/a/news/regional/enhertu-combination-shows-promising-results-in-early-breast-cancer-trial/","snapshot":"source-4.html.gz","status":"MyChesCo press-release relay. Verifies Harbeck (LMU Munich) and Galbraith (AstraZeneca oncology R&D EVP) full quotes verbatim."},"source-5":{"url":"https://oncodaily.com/oncolibrary/destiny-breast11-t-dxd-pcr-ebc","snapshot":"source-5.html.gz","status":"OncoDaily DESTINY-Breast11 expanded coverage. Verifies HR subgroup splits (61.4% vs 52.3% HR+, 83.1% vs 67.1% HR-), RCB 0/I rates (81.3% vs 69.1%), grade ≥3 AE 37.5% vs 55.8%, SAE 10.2% vs 20.2%, LVD 1.9% vs 9.0%, T-DXd monotherapy arm closed March 2024 per IDMC."},"source-6":{"url":"https://oncodaily.com/oncolibrary/destiny-breast05-esmo-2025-tdxd-tdm1","snapshot":"source-6.html.gz","status":"OncoDaily DESTINY-Breast05 ESMO 2025 coverage. Verifies grade ≥3 TEAE 50.6% vs 51.9% and treatment-related death 0.4% vs 0.6%."}}

Exemplary biotech submission with textbook Rule 9 discipline — both PubMed primaries (NEJM DESTINY-Breast05, Annals of Oncology DESTINY-Breast11) cited directly. Every clinical specific verified verbatim: 927-patient DESTINY-Breast11 (286/321/320 arm splits, T-DXd alone closed early March 2024 per IDMC), pCR 67.3% (216/321) vs 56.3% (180/320) vs 43.0% T-DXd monotherapy, 11.2pp absolute difference 95% CI 4.0%-18.3% P=0.003, HR subgroup splits (HR+ 61.4% vs 52.3%; HR- 83.1% vs 67.1%), RCB 0/I 81.3% vs 69.1%, grade ≥3 AE 37.5% vs 55.8%, SAE 10.2% vs 20.2%, LVD 1.9% vs 9.0%, EFS HR 0.56 (95% CI 0.26-1.17) at 4.5% maturity. DESTINY-Breast05 (1,635 patients, 818/817 split, 3-year IDFS 92.4% vs 83.7%, HR 0.47 95% CI 0.34-0.66 P<0.001, events 6.2% vs 12.5%, '53% reduction in risk' AstraZeneca framing, ILD 9.6% vs 1.6% with 2 ILD deaths, grade ≥3 TEAE 50.6% vs 51.9%, treatment-related death 0.4% vs 0.6%). NEJM publication date Feb 26 2026 verified in PubMed. Both direct quotes (Harbeck 'most effective treatment at the earliest opportunity is critical' / Galbraith 'impressive pathologic response rates and favorable safety profile') verbatim. Label warnings (ILD/pneumonitis boxed, neutropenia, LVD) verified. Dose (5.4 mg/kg q3w, 4 cycles neoadjuvant, up to 14 cycles adjuvant) verified.