Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized bevacizumab in combination with erlotinib for the first-line treatment of adult patients with unresectable advanced, metastatic, or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating variants. This indication is based on JO25567, a randomized, open-label, multi-centre phase 2 study that defined EGFR activating variants as either exon 19 deletions or exon 21 p.L858R.

This is written in the approval document as:

Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations.

Citation

Mabxience Research SL. Avastin (bevacizumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf. Revised March 2023. Accessed March 11, 2024.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	EGFR p.L858R	Non-Small Cell Lung Cancer	Bevacizumab, Erlotinib
EMA (1)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Bevacizumab, Erlotinib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2016-06-02	European Medicines Agency	Indication received approval from the European Commission.