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FDA Medication Tracker

← All approvals · Cancer · 2024

Bizengri (zenocutuzumab-zbco)

The FDA approved Bizengri (zenocutuzumab-zbco) on December 4, 2024 to treat non-small cell lung cancer and pancreatic adenocarcinoma.
Brand name
Bizengri
Generic name
zenocutuzumab-zbco
FDA approval date
December 4, 2024
Approved use (FDA wording)
To treat non-small cell lung cancer and pancreatic adenocarcinoma
Company
Merus N.V.
Application
BLA761352
Dosage form / route
INJECTION · SOLUTION
Boxed warning on label
Yes (see the FDA label)
Category on this site
Cancer

Indications and usage, from the FDA label

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.* ( 1.1 ) Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.2 ) Adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. ( 1.3 ) *This indication is approved under …

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.