Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to ramucirumab in combination with erlotinib for the first-line treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.

This is written in the approval document as:

CYRAMZA is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist 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.

Citation

Eli and Lily Company. Cyramza (ramucirumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125477s042lbl.pdf. Revised March 2022. Accessed October 30, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Erlotinib, Ramucirumab
FDA (2)	EGFR p.L858R	Non-Small Cell Lung Cancer	Erlotinib, Ramucirumab

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2020-05-29	Food and Drug Administration	Indication received traditional approval.