Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval.
On December 4, 2024, the FDA granted accelerated approval to zenocutuzumab-zbco (brand name Bizengri) for adults with the following:
- advanced, unresectable, or metastatic non-small cell lung cancer harboring a neuregulin 1 gene fusion with disease progression on or after prior systemic therapy, or
- advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 gene fusion with disease progression on or after prior systemic therapy.
This represents the first FDA approval of a systemic therapy for patients with non-small cell lung cancer or pancreatic adenocarcinoma harboring a neuregulin 1 gene fusion.
Efficacy was evaluated in the eNRGy study, a multicenter, open-label, multicohort trial. The trial enrolled 64 adults with advanced or metastatic neuregulin 1 fusion-positive non-small cell lung cancer and 30 adults with advanced or metastatic neuregulin 1 fusion-positive pancreatic adenocarcinoma who had disease progression following standard of care treatment. Identification of positive neuregulin 1 gene fusion status was prospectively determined by next generation sequencing assays.
The major efficacy outcome measures were confirmed overall response rate and duration of response, determined by blinded independent central review according to RECIST v1.1. For non-small cell lung cancer, overall response rate was 33% and median duration of response was 7.4 months. For pancreatic adenocarcinoma, overall response rate was 40% and the duration of response range was 3.7 months to 16.6 months.
The prescribing information includes a Boxed Warning for embryo-fetal toxicity.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
Full prescribing information for these approvals can be found on the web at www.fda.gov/drugsatfda.
Health care professionals should report serious adverse events to www.fda.gov/medwatch.
Follow the Division of Drug Information on X @FDA_Drug_Info and Oncology Center of Excellence @FDAOncology. Send your feedback via email to FDAOncology@fda.hhs.gov.
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