Regulatory approval

Published by the Food and Drug Administration.

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.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) EGFR Exon 19 (Deletion) Non-Small Cell Lung Cancer Erlotinib, Ramucirumab
Sensitivity (+) EGFR p.L858R Non-Small Cell Lung Cancer Erlotinib, Ramucirumab