…………………. catching up on recent FDA approvals
The FDA recently approved a new infused therapy, Bizengri (zenocutuzumab-zbco) from Merus N.V., 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.
Bizengri is a bispecific antibody that binds to the extracellular domains of HER2 and HER3 expressed on the surface of cells, including tumor cells, inhibiting HER2:HER3 dimerization and preventing NRG1 binding to HER3. The therapy is the first and only treatment approved for these indications. Approval for these indications may be contingent upon verification of clinical benefit in a confirmatory trial(s).
Bizengri was approved with a Black Box warning for Embryo-Fetal Toxicity.
The company did not announce the price for Bizengri.
Similarly, the company did not announce plans for distribution.
CLICK HERE to access prescribing information
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Merus Announces FDA Approval of Bizengri (zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NRG1+ Non–Small Cell Lung Cancer (NSCLC)
