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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

May 29, 2020Approval Lilly's Cyramza (ramucirumab) Receives FDA Approval as First-Line Treatment for Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
May 13, 2019Approval Lilly's Cyramza (ramucirumab) Becomes First FDA-Approved Biomarker-Driven Therapy in Patients with Hepatocellular Carcinoma
Apr 24, 2015Approval FDA Approves Cyramza (Ramucirumab) for Use with FOLFIRI in Second-Line Treatment of Metastatic Colorectal Cancer
Dec 12, 2014Approval FDA Expands Approved use of Cyramza to Treat Aggressive Non-Small Cell Lung Cancer
Nov  5, 2014Approval FDA Approves Cyramza (ramucirumab) in Combination with Paclitaxel for Advanced Gastric Cancer after Prior Chemotherapy
Apr 21, 2014Approval FDA Approves Cyramza for Stomach Cancer

Further information

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