Ramucirumab
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Ramucirumab
- Ramucirumab: From Non-Small Cell Lung Cancer and Gastric Adenocarcinoma to Uterine Ligament Adenocarcinoma
Ramucirumab: From Non-Small Cell Lung Cancer and Gastric Adenocarcinoma to Uterine Ligament Adenocarcinoma
One-Sentence Summary
Ramucirumab is a monoclonal antibody originally used to treat solid tumours such as non-small cell lung carcinoma, gastric adenocarcinoma and hepatocellular carcinoma. The TxGNN model predicts it may be effective for uterine ligament adenocarcinoma, but currently there are 0 clinical trials and 0 publications supporting this prediction, so it rests on model prediction alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Non-small cell lung carcinoma, gastric adenocarcinoma, hepatocellular carcinoma (the data compiled for this report contains no approved-indication text from the license record) |
| Predicted New Indication | Uterine ligament adenocarcinoma |
| TxGNN Prediction Score | 99.95% |
| Evidence Level | L5 |
| US Market Status | Cancelled only |
| Number of NDAs | 1 (BLA125477) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on general drug knowledge, ramucirumab is a VEGFR-2 antagonist, and its established indications (gastric adenocarcinoma, non-small cell lung cancer, hepatocellular carcinoma) are tumours in which VEGF/VEGFR-2 signalling and angiogenesis play a role. This mechanistic description is an inference and is not drawn from the supplied data.
Uterine ligament adenocarcinoma is a gynaecological adenocarcinoma, so an anti-angiogenic rationale is plausible. However, no direct data were available for this entity, and the link between the original and new indications remains theoretical.
Nine other gynaecological adenocarcinoma predictions (such as endocervical carcinoma and several rare cervical and uterine ligament subtypes) received similarly high scores (99.93%–99.95%). Some of these, such as the signet ring cell and intestinal variants, share histology with gastrointestinal adenocarcinoma, which may partly explain the high scores. Histologic overlap is not evidence of efficacy.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| BLA125477 | CYRAMZA (Eli Lilly and Company) | Solution | Not available; status: cancelled |
Cytotoxicity
| Item | Content |
|---|---|
| Cytotoxicity Classification | Targeted therapy (monoclonal antibody against VEGFR-2) |
| Myelosuppression Risk | Please refer to the package insert warnings and precautions |
| Emetogenicity Classification | Please refer to the package insert warnings and precautions |
| Monitoring Items | Please refer to the package insert warnings and precautions |
| Handling Protection | Please refer to the package insert warnings and precautions |
Safety Considerations
- Drug Interactions: The interaction query identified 100 interacting drugs in total; 20 were returned in the compiled data. Most are rated Major, and many involve bleeding risk, including:
- Antiplatelet and antithrombotic agents: acetylsalicylic acid, clopidogrel, cilostazol, cangrelor, abciximab, caplacizumab, defibrotide
- Anticoagulants and thrombolytics: apixaban, betrixaban, bivalirudin, dalteparin, antithrombin III, alteplase
- Others rated Major: deferasirox, and the radiolabelled agents ibritumomab tiuxetan and tositumomab
- Rated Moderate: dexfenfluramine, fenfluramine, sibutramine
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is supported only by the TxGNN score (Evidence Level L5), with no clinical trials or publications for uterine ligament adenocarcinoma. The only US licence on record is cancelled, and warnings and contraindications are not available, so safety screening cannot proceed.
To proceed, the following is needed:
- Package insert warnings and contraindications (a blocking gap for safety screening)
- Detailed mechanism of action data
- Preclinical or clinical evidence in uterine ligament or related gynaecological adenocarcinomas, such as a literature and trial registry search
- Clarification of the cancelled US licence status and current availability
- A bleeding-risk management plan given the many major interactions with anticoagulant and antiplatelet drugs
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.