Drug updated on 12/11/2024
Dosage Form | Injection (intravenous; 100 mg/10 mL [10 mg/mL], 500 mg/50 mL [10 mg/mL]) |
Drug Class | Human vascular endothelial growth factor receptor 2 (VEGFR2) antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as a single agent or in combination with paclitaxel, for treatment of advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy
- Indicated in combination with erlotinib, for first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations
- Indicated in combination with docetaxel, for treatment of metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy
- Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA
- Indicated in combination with FOLFIRI, for the treatment of metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine
- Indicated as a single agent, for the treatment of hepatocellular carcinoma in patients who have an alpha fetoprotein of 400 ng/mL and have been treated with sorafenib
Latest News
Summary
- This summary is based on the review of 29 systematic review(s)/meta-analysis(es). [1-29]
- Gastroesophageal Adenocarcinoma (GEA): Ramucirumab (RAM) combined with folinic acid, fluorouracil and irinotecan (FOLFIRI) or irinotecan achieved an overall response rate (ORR) ranging from 22% to 38%, with a pooled ORR of 25.4%. In combination with paclitaxel, RAM improved median overall survival (mOS) to 9.3-12.2 months and median progression-free survival (mPFS) to 4.1-5.1 months compared to paclitaxel alone (mOS: 5.2-9.7 months, mPFS: 3.0-4.1 months).
- Hepatocellular Carcinoma (HCC): RAM provided progression-free survival benefits (hazard ratio (HR) = 0.44) similar to regorafenib and cabozantinib, with an overall survival benefit (HR = 0.82) over placebo. However, regorafenib and cabozantinib offered greater overall survival (OS) improvements (HR = 0.62 and HR = 0.74, respectively).
- Non-Small Cell Lung Cancer (NSCLC): RAM plus docetaxel achieved a median OS of 11.2 months in patients pretreated with immune checkpoint inhibitors (ICI) and 13.5 months in ICI-naive patients. Median PFS was 5.7 months for ICI-pretreated and 3.8 months for ICI-naive patients.
- Epidermal Growth Factor Receptor (EGFR)-Mutated NSCLC: RAM combined with erlotinib demonstrated progression-free survival outcomes comparable to osimertinib and dacomitinib, with no significant difference in overall survival among treatments.
- Gastroesophageal Adenocarcinoma (GEA) Safety: For RAM combined with FOLFIRI or irinotecan, neutropenia and diarrhea were the most commonly reported adverse events. In combination with paclitaxel, hematological toxicities were frequent, with low discontinuation rates due to adverse events (3.3-6.3%).
- Hepatocellular Carcinoma (HCC) Safety: Ramucirumab exhibited an established safety profile with no significant new safety concerns, showing consistent safety across patient subgroups.
- EGFR-Mutated NSCLC Safety: RAM combined with erlotinib increased the incidence of serious adverse events, particularly diarrhea, proteinuria, and hypertension, showing a higher risk of serious adverse events compared to erlotinib alone.
- RAM demonstrated higher ORR in GEA patients pretreated with taxanes and improved mPFS in patients with prior anti-PD-1 exposure. In HCC, RAM showed effectiveness regardless of elevated AFP levels, and in NSCLC, RAM combined with docetaxel had consistent effectiveness and safety across patients, regardless of prior ICI treatment. In EGFR-mutated NSCLC, RAM with erlotinib provided comparable PFS benefits across subgroups, including those with exon 19 deletions and L858R mutations.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Cyramza (ramucirumab) Prescribing Information. | 2022 | Eli Lilly and Company |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Systemic Therapy for Advanced Hepatocellular Carcinoma: ASCO Guideline Update. | 2024 | Journal of Clinical Oncology |
Immunotherapy and Targeted Therapy for Advanced Gastroesophageal Cancer: ASCO Guideline | 2023 | Journal of Clinical Oncology |
AGA Clinical Practice Guideline on Systemic Therapy for Hepatocellular Carcinoma. | 2022 | Gastroenterology |
Updated treatment recommendations for hepatocellular carcinoma (HCC) from the ESMO Clinical Practice Guidelines. | 2021 | Annals of Oncology |
Argentinian clinical practice guideline for surveillance, diagnosis, staging and treatment of hepatocellular carcinoma | 2020 | Annals of Hepatology |