FDA Grants Accelerated Approval to Bizengri for NRG1+ Pancreatic adenocarcinoma and NRG1+ Non–Small Cell Lung Cancer
Merus N.V. has announced that the U.S. Food and Drug Administration (FDA) approved Bizengri (zenocutuzumab-zbco). This is the first and only treatment indicated for adults with pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC); that are advanced, unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion; who have disease progression on or after prior systemic therapy.
These indications are approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Bizengri has a Boxed WARNING for Embryo-Fetal Toxicity and warnings for infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions, interstitial lung disease (ILD)/pneumonitis, and left ventricular dysfunction.
- Bizengri is a bispecific antibody that binds to the extracellular domain of HER2 and HER3 expressed on the surface of cells, including tumor cells, inhibiting HER2:HER3 dimerization and preventing NRG1 binding to HER3.
- The company plans to help appropriate patients gain access to Bizengri by providing resources and support based on each patient’s needs and situation.
Source: Meru N.V.
