FDA Grants Accelerated Approval to Zenocutuzumab-zbco for NSCLC and Pancreatic Adenocarcinoma
On December 4, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval for zenocutuzumab-zbco (brand name Bizengri) as a new treatment option for adults with advanced or metastatic non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma that harbor an NRG1 gene fusion.
This marks an important step forward in cancer treatment, as zenocutuzumab-zbco becomes the first systemic therapy approved by the FDA for patients with these two types of cancer who carry the NRG1 gene fusion.
The approval is based on data from the eNRGy study, a multicenter, open-label, and multicohort clinical trial. The study enrolled 64 adults with NRG1 fusion-positive NSCLC and 30 adults with NRG1 fusion-positive pancreatic adenocarcinoma, all of whom had disease progression following prior systemic therapy.
The study demonstrated promising efficacy, with an overall response rate (ORR) of 33% for patients with NSCLC and 40% for those with pancreatic adenocarcinoma.
For NSCLC patients, the median duration of response (DOR) was 7.4 months, while for pancreatic adenocarcinoma patients, the DOR ranged from 3.7 to 16.6 months.
In terms of safety, the most common side effects experienced by patients included diarrhea, musculoskeletal pain, fatigue, nausea, and infusion-related reactions.
A Boxed Warning has been included in the prescribing information for zenocutuzumab-zbco, indicating potential risks of embryo-fetal toxicity, which healthcare providers should carefully consider before prescribing the drug to patients who are pregnant or planning to become pregnant.
The recommended dose of zenocutuzumab-zbco is 750 mg, administered via intravenous infusion every two weeks, until disease progression or unacceptable toxicity occurs.
This approval provides new hope for patients with difficult-to-treat cancers and reinforces the importance of targeted therapies in oncology, which are increasingly focused on genetic alterations such as the NRG1 gene fusion.
This breakthrough approval reflects the growing promise of precision medicine in cancer treatment, offering a more tailored approach to therapies and providing new options for patients facing some of the most challenging and aggressive cancers.
With its focus on specific genetic mutations, zenocutuzumab-zbco offers a targeted treatment that could potentially improve outcomes for those who have not responded to traditional therapies.
Doctors shared their insights about the trial on social media:
“FDA grants accelerated approval to zenocutuzumab for non-small cell lung cancer & pancreatic adenocarcinoma.
- first FDA approval for NRG1 gene fusion.
- Rare, but can be found in multiple cancer types incl. CCA.
- options for chemotherapy.”
“Zenocutuzumab her2/3 bispecific antibody gets USFDA accerelated approval for second line NSCLC and PADC pts With NRG1 fusion.
New Drug approval.
We need NGS to pick up this RNA fusion.”
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