FDA D.I.S.C.O. Burst Edition: FDA approval of Bizengri (zenocutuzumab-zbco) for Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy

Regulatory approval: On Dec 4, 2024, the FDA granted accelerated approval to zenocutuzumab-zbco (Bizengri) for adults with advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring an NRG1 gene fusion whose disease progressed on or after prior systemic therapy. Efficacy was evaluated in the multicenter, open-label eNRGy trial; in the pancreatic cohort (n=30), confirmed ORR was 40%, with duration of response ranging from 3.7 to 16.6 months. Labeling includes a boxed warning for embryo-fetal toxicity.

FDA accelerated approval (regulatory news)

On Dec 4, 2024, the FDA granted accelerated approval to zenocutuzumab-zbco (Bizengri) for adults with advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

The FDA announcement also described accelerated approval in NRG1 fusion–positive non-small cell lung cancer with progression after prior systemic therapy, and stated this is the first FDA approval of a systemic therapy for patients with NRG1 gene fusion–positive NSCLC or pancreatic adenocarcinoma.

Supporting evidence

Efficacy was evaluated in eNRGy, a multicenter, open-label, multicohort trial enrolling:

  • 30 adults with advanced or metastatic NRG1 fusion–positive pancreatic adenocarcinoma
  • 64 adults with advanced or metastatic NRG1 fusion–positive NSCLC

NRG1 fusion status was prospectively determined using next-generation sequencing assays.

Major efficacy endpoints were confirmed overall response rate (ORR) and duration of response (DOR) by blinded independent central review per RECIST v1.1. In the pancreatic adenocarcinoma cohort, ORR was 40% and DOR ranged from 3.7 to 16.6 months.

Safety

The prescribing information includes a Boxed Warning for embryo-fetal toxicity.

Full prescribing information is available at www.fda.gov/drugsatfda.

Sources