FDA Approves Bizengri for Some with NSCLC, Pancreatic Adenocarcinoma

Author(s):

Alex Biese

Fact checked by:

Spencer Feldman

Key Takeaways

Bizengri received FDA approval for NSCLC and pancreatic adenocarcinoma with NRG1 gene fusion after prior therapy failure.
The eNRGy study showed a 33% ORR in NSCLC and 40% in pancreatic adenocarcinoma, with varying DOR.
Common side effects include diarrhea, fatigue, and nausea, with severe lab abnormalities like increased gamma-glutamyl transferase.
Bizengri's recommended dose is 750 mg intravenously every two weeks, with a Boxed Warning for embryo-fetal toxicity.

The FDA has approved the first systemic therapy for patients with NSCLC or pancreatic adenocarcinoma with an NRG1 gene fusion.

The FDA has approved Bizengri for the treatment of patients with advanced or metastatic NSCLC or pancreatic adenocarcinoma with an NRG1 gene fusion.

The Food and Drug Administration (FDA) has granted the first approval for a systemic therapy for patients with non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma with an NRG1 gene fusion, the agency announced.

The FDA granted accelerated approval to Bizengri (zenocutuzumab-zbco) for the treatment of advanced, unresectable or metastatic NSCLC with a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy and for the treatment of advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy.

The efficacy of Bizengri was determined in the eNRGy study of 64 adults with advanced or metastatic NRG1 fusion-positive NSCLC and 30 adults with advanced or metastatic NRG1 fusion-positive pancreatic adenocarcinoma who had experienced disease progression after undergoing standard-of-care treatment.

Among the patients with NSCLC, the objective response rate (ORR) was 33% and the median duration of response (DOR) was 7.4 months. Among patients with pancreatic adenocarcinoma, the ORR was 40% and the DOR ranged from 3.7 months to 16.6 months, according to the agency.

The most common side effects experienced by at least 10% of patients were diarrhea, musculoskeletal pain, fatigue, nausea, infusion-related reactions, dyspnea, rash, constipation, vomiting, abdominal pain and edema. The most common grade 3 (severe) or 4 (life-threatening) laboratory abnormalities were increased gamma-glutamyl transferase, decreased hemoglobin, decreased sodium and decreased platelets and the prescribing information contains a Boxed Warning for embryo-fetal toxicity.

The recommended dose of Bizengri, according to the agency, is 750 milligrams as an intravenous infusion every two weeks until disease progression or unacceptable toxicity.

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