Regulatory approval

Published by the Food and Drug Administration. Accelerated

The U.S. Food and Drug Administration (FDA) granted accelerated approval to zenocutuzumab for the treatment of adult patients with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. The package insert notes that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

This is written in the approval document as:

BIZENGRI is a bispecific HER2- and HER3-directed antibody indicated for the treatment of adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Citation

Merus N.V. Bizengri (zenocutuzumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761352s010lbl.pdf. Revised May 2026. Accessed October 8, 2026.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	v::NRG1	Non-Small Cell Lung Cancer	Zenocutuzumab

Contributions

Date	Contributor	Description
2025-01-10	Van Allen lab	Additional FDA approvals for initial version
2024-12-04	Food and Drug Administration	Indication received accelerated approval.