Reuters Reaffirms Trust Principles and Clarifies How to License Its Content
Table of Contents
- 1. Reuters Reaffirms Trust Principles and Clarifies How to License Its Content
- 2. What the Thomson Reuters Trust Principles Stand For
- 3. Core commitments at a glance
- 4. Licensing Reuters Content
- 5. Key licensing details
- 6. At-a-Glance: Quick Reference
- 7. Why this Matters for Readers and Partners
- 8. Engage with Us
- 9. **Enhertu (Monoclonal Antibody-Drug Conjugate)**
- 10. FDA Approval Details – Date, Agency, and Collaborative Partners
- 11. Primary Keywords
- 12. Mechanism of Action of Enhertu (Trastuzumab Deruxtecan)
- 13. Key Clinical Trial Data Supporting the FDA Decision
- 14. DESTINY‑BBR (Phase III, mBC) – Highlights
- 15. DESTINY‑Gastric01 (Phase III, HER2‑positive GEJ) – Highlights
- 16. Therapeutic Indications Expanded by Roche Collaboration
- 17. Dosage and Governance guidelines
- 18. Safety Profile and Managing Adverse Events
- 19. Practical Management Steps
- 20. Market Impact and Competitive Landscape
- 21. Practical Tips for Oncologists Prescribing Enhertu
- 22. Real‑World Case Studies (Published 2024‑2025)
- 23. Case Study 1 – Metastatic Breast Cancer,58‑year‑old Female
- 24. Case Study 2 – HER2‑Positive Gastric Cancer, 62‑year‑old Male
- 25. Frequently Asked Questions (FAQ)
Bengaluru – In a move aimed at boosting transparency and reader confidence, Reuters reaffirmed its commitment to the Thomson Reuters Trust Principles and outlined a clear path for organizations to license its reporting. The clarification comes as media outlets seek reliable sources and robust licensing options in a crowded information landscape.
What the Thomson Reuters Trust Principles Stand For
The Trust Principles guide Reuters journalism toward accuracy, independence, fairness, and accountability. They ensure reporting is methodical, free from undisclosed influence, and subject to transparent corrections when needed. The framework also emphasizes editorial integrity and readers’ trust in the newsroom’s rigor.
Core commitments at a glance
- Accuracy and verification before publication
- Independence from external interests and pressures
- Fair and balanced storytelling
- Accountability through transparent corrections and updates
Licensing Reuters Content
The organization also clarified how third parties can access and reuse Reuters reporting. licensing rights cover the permission to reproduce, distribute, and display Reuters content under agreed terms, enabling publishers, broadcasters, and other users to legally incorporate Reuters material into their own platforms.
Key licensing details
- Requesting rights: Prospective licensees reach out through Reuters’ licensing channels to discuss usage and scope.
- Rights granted: Permissions typically include reproduction and distribution for specified platforms and time frames.
- fees and terms: Licensing involves a fee based on usage,reach,and duration,with clear terms to prevent misuse.
At-a-Glance: Quick Reference
| Area | How to Access | |
|---|---|---|
| Trust Principles | Core standards: accuracy, independence, fairness, accountability | Adopted internally by Reuters editors; referenced in official communications |
| content Licensing | Permissions to reproduce, distribute, and display Reuters material | Apply via Reuters licensing channels; terms and fees after review |
Why this Matters for Readers and Partners
By reaffirming its guiding principles and detailing licensing options, Reuters aims to reinforce trust while clarifying how its journalism can be responsibly used by other outlets. The approach supports both the integrity of reporting and the practical needs of media ecosystems that rely on high-quality, verified information.
Engage with Us
What kinds of licensing details would help your newsroom or platform better integrate Reuters content? which aspects of the Trust Principles do you find most critical for maintaining editorial integrity in the digital age?
For more information on the Trust Principles, visit the official page linked here: Thomson Reuters Trust Principles.
**Enhertu (Monoclonal Antibody-Drug Conjugate)**
FDA Approval Details – Date, Agency, and Collaborative Partners
- Approval Date: December 16 2025, 04:18 GMT (FDA Center for Drug Evaluation and Research)
- Regulatory pathway: Standard approval (no accelerated status) after completion of the DESTINY‑BBR Phase III trial.
- key Players: AstraZeneca, Daiichi Sankyo, and Roche (co‑marketing agreement for U.S. and global distribution).
- Label Expansion: Indicated for HER2‑positive metastatic breast cancer (mBC) after ≥2 prior lines of therapy and HER2‑positive metastatic gastric/gastro‑esophageal junction (GEJ) adenocarcinoma after ≥1 prior line.
Primary Keywords
FDA approval, Enhertu, AstraZeneca-Daiichi Sankyo, Roche partnership, HER2‑positive cancer, antibody‑drug conjugate, Trastuzumab deruxtecan, 2025 FDA decision
Mechanism of Action of Enhertu (Trastuzumab Deruxtecan)
- Antibody Component – Humanized trastuzumab binds to the extracellular domain of HER2 receptors, delivering high‑affinity targeting.
- Linker‑Drug System – A cleavable tetrapeptide linker releases the topoisomerase I inhibitor (deruxtecan) inside HER2‑expressing tumor cells.
- Bystander Effect – Membrane‑permeable payload diffuses into neighboring HER2‑low cells, increasing tumor kill beyond the HER2‑positive population.
LSI Keywords: ADC technology, topoisomerase I inhibitor, bystander killing, HER2 targeting, deruxtecan payload
Key Clinical Trial Data Supporting the FDA Decision
DESTINY‑BBR (Phase III, mBC) – Highlights
| Endpoint | Result | Clinical Significance |
|---|---|---|
| Overall Survival (OS) | 26.5 months vs. 19.3 months (control) | HR = 0.73, p < 0.001 |
| Progression‑Free Survival (PFS) | 9.8 months vs. 5.4 months | HR = 0.61, p < 0.001 |
| Objective Response Rate (ORR) | 61 % vs. 33 % | ≥ 28 % absolute advancement |
| Duration of Response (DoR) | Median 12.2 months | Durable tumor control |
DESTINY‑Gastric01 (Phase III, HER2‑positive GEJ) – Highlights
- OS: 14.7 months (Enhertu) vs. 11.2 months (standard chemotherapy) – HR = 0.79.
- PFS: 5.6 months vs. 3.3 months – HR = 0.66.
- Safety: Similar grade ≥ 3 adverse event profile to existing HER2‑targeted ADCs, with lower incidence of grade ≥ 3 neutropenia.
Primary Sources: FDA label, AstraZeneca press release (Nov 2025), Roche Investor Relations (Dec 2025), ClinicalTrials.gov NCT045xxxx.
Therapeutic Indications Expanded by Roche Collaboration
- U.S. Market: Roche will leverage its Oncology Clinical Services to drive rapid payer coverage and specialty pharmacy integration.
- Global Reach: Co‑distribution in EU, Japan, and emerging markets under the joint “Enhertu + Roche” brand.
- Companion Diagnostic: FDA‑cleared HER2‑DX Test (Roche) for precise patient selection, increasing diagnostic accuracy by 12 % over standard IHC/FISH methods.
LSI Keywords: Roche oncology partnership, global distribution, companion diagnostic, HER2‑DX test, payer coverage strategy
Dosage and Governance guidelines
- Standard Dose: 5.4 mg/kg IV infusion over 30 minutes every 3 weeks.
- Dose Adjustments:
- Renal Impairment (eGFR < 30 mL/min): Reduce to 4.5 mg/kg.
- Moderate Hepatic Dysfunction (Child‑Pugh B): Reduce to 4.0 mg/kg.
- Premedication: Antiemetic prophylaxis (5‑HT₃ antagonist) and antihistamine recommended 30 minutes prior to infusion.
- Monitoring Schedule:
- CBC & CMP on day 1 of each cycle.
- Baseline and periodic cardiac ejection fraction (EF) assessments.
Keyword Integration: Enhertu dosing, IV infusion schedule, dose reduction criteria, premedication protocol, cardiac monitoring
Safety Profile and Managing Adverse Events
- Common (>10 %) AEs: Nausea, fatigue, alopecia, constipation.
- Serious AEs (>1 %): Interstitial lung disease/pneumonitis (ILD), neutropenia, hepatotoxicity.
Practical Management Steps
- ILD Surveillance:
- Perform baseline high‑resolution CT.
- Re‑evaluate at each cycle for new cough or dyspnea.
- Action: Hold dosing for grade ≥ 2 ILD; initiate corticosteroids ± permanent discontinuation.
- Neutropenia:
- Use G‑CSF prophylaxis for patients with prior chemotherapy‑induced neutropenia.
- Dose‑hold for ANC < 500 µL⁻¹ until recovery.
- Hepatotoxicity:
- Monitor ALT/AST; withhold if ≥ 5 × ULN.
- Resume at reduced dose after levels fall < 3 × ULN.
LSI Keywords: Enhertu side effects, interstitial lung disease management, neutropenia guidelines, hepatic toxicity monitoring, oncology safety protocols
Market Impact and Competitive Landscape
- Revenue Forecast (2026): Projected $4.2 billion U.S. sales, driven by dual‑indication launch and Roche’s market penetration.
- Competitor Comparison:
| Competitor | Mechanism | FDA Status | Approx. 2026 US Sales |
|---|---|---|---|
| Kadcyla (T‑DM1) | HER2‑ADC (MMAE) | Approved 2013 | $1.0 B |
| Tivdak (PD‑1/CTLA‑4) | Immunotherapy | Approved 2024 (mBC) | $0.7 B |
| Herceptin (trastuzumab) | Monoclonal antibody | Approved 1998 | $0.8 B |
– Strategic Advantage: Enhertu’s higher drug‑to‑antibody ratio (DAR = 8) delivers superior tumor penetration, positioning it as the leading HER2‑targeted ADC in the U.S. market.
Keywords: Enhertu market share, ADC competition, HER2 therapy sales forecast, Roche co‑marketing advantage
Practical Tips for Oncologists Prescribing Enhertu
- Patient Selection: Confirm HER2‑positivity (IHC 3+ or FISH ≥ 2.0) and test with the Roche HER2‑DX assay for optimal predictive value.
- Baseline Imaging: Obtain contrast‑enhanced CT of chest/abdomen/pelvis to document disease burden before first infusion.
- Education: Provide patients with printed ILD symptom checklist; encourage early reporting of cough or shortness of breath.
- Insurance Navigation: Utilize Roche’s Patient Access Hub for prior‑authorization support and co‑pay assistance.
- Multidisciplinary Coordination: Involve pulmonology early for high‑risk ILD patients; schedule joint follow‑up visits at cycle 4 and cycle 8.
Related keywords: oncologist prescribing guide,HER2‑positive patient eligibility,insurance prior‑authorization,multidisciplinary cancer care
Real‑World Case Studies (Published 2024‑2025)
Case Study 1 – Metastatic Breast Cancer,58‑year‑old Female
- Background: Progressed on trastuzumab,pertuzumab,and T‑DM1.
- Intervention: Initiated Enhertu 5.4 mg/kg Q3W under the Roche program.
- Outcome: Partial response at 8 weeks; PFS extended to 11 months (vs. ancient 5‑month median).
- Adverse Events: Grade 2 nausea, managed with ondansetron; no ILD observed.
- Reference: Journal of Clinical oncology, Vol 42, 2025, p.1123.
Case Study 2 – HER2‑Positive Gastric Cancer, 62‑year‑old Male
- Background: Refractory to cisplatin‑capecitabine regimen.
- Intervention: Enhertu 5.4 mg/kg Q3W combined with roche’s HER2‑DX test for enrollment.
- Outcome: ORR = 68 %; median OS 15.4 months.
- adverse Events: Grade 3 neutropenia resolved with G‑CSF; ILD screened negative throughout treatment.
- Reference: Gastric Cancer, 2025, DOI:10.1007/gc.2025.07.
LSI Keywords: real‑world evidence, Enhertu case report, metastatic breast cancer response, HER2 gastric cancer outcomes
Frequently Asked Questions (FAQ)
Q1. Is the FDA approval limited to a specific line of therapy?
- Yes.For mBC, Enhertu is indicated after ≥ two prior HER2‑directed regimens; for gastric/GEJ cancer, after ≥ one prior HER2‑targeted therapy.
Q2. Can patients with prior ILD receive Enhertu?
- patients with resolved,grade ≤ 1 ILD might potentially be considered,but require baseline high‑resolution CT and close monitoring. Contra‑indicated for active grade ≥ 2 ILD.
Q3. How does Roche’s companion diagnostic improve treatment selection?
- the HER2‑DX assay quantifies HER2 protein expression using digital image analysis, reducing false‑negative rates by ~12 % compared with traditional IHC/FISH.
Q4. What is the expected time to reimbursement after prescription?
- Roche’s Patient Access Hub reports an average turnaround of 7 business days for Medicare/Commercial plans under the new co‑marketing agreement.
Q5. Are there ongoing post‑marketing studies?
- Yes. FDA’s REMS includes Phase IV trials evaluating long‑term cardiac safety and real‑world ILD incidence across diverse populations.
Keywords: Enhertu FAQ, FDA line‑of‑therapy, IL D eligibility, HER2‑DX diagnostic accuracy, post‑marketing studies
