Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that v::NRG1 status confers therapeutic sensitivity to Zenocutuzumab in patients with Non-Small Cell Lung Cancer.
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 statement is based on a regulatory approval from the Food and Drug Administration:
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).