Cyramza FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved April 21, 2014)
Brand name: Cyramza
Generic name: ramucirumab
Dosage form: Injection
Company: Eli Lilly and Company
Treatment for: Gastric Cancer, Non Small Cell Lung Cancer, Colorectal Cancer, Hepatocellular Carcinoma

Cyramza (ramucirumab) is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated:

as a single agent or in combination with paclitaxel, for treatment of advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
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.
in combination with docetaxel, for treatment of metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy.
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.
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.

Development timeline for Cyramza

Date	Article
Oct 9, 2023	First Patient Dosed in the Phase 3 Clinical Study of Efdamrofusp Alfa For the Treatment of Neovascular Age-related Macular Degeneration
May 29, 2020	Approval Lilly's Cyramza (ramucirumab) Receives FDA Approval as First-Line Treatment for Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
May 13, 2019	Approval Lilly's Cyramza (ramucirumab) Becomes First FDA-Approved Biomarker-Driven Therapy in Patients with Hepatocellular Carcinoma
Apr 24, 2015	Approval FDA Approves Cyramza (Ramucirumab) for Use with FOLFIRI in Second-Line Treatment of Metastatic Colorectal Cancer
Dec 12, 2014	Approval FDA Expands Approved use of Cyramza to Treat Aggressive Non-Small Cell Lung Cancer
Nov 5, 2014	Approval FDA Approves Cyramza (ramucirumab) in Combination with Paclitaxel for Advanced Gastric Cancer after Prior Chemotherapy
Apr 21, 2014	Approval FDA Approves Cyramza for Stomach Cancer

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA