What the FDA Approval of Bizengri Means for Patients With NRG1-Positive NSCLC

The Food and Drug Administration (FDA) has granted its first approval for a systemic therapy for patients with non-small cell lung cancer (NSCLC) with an Neuregulin 1 (NRG1) gene fusion, with the accelerated approval of Bizengri (zenocutuzumab-zbco).

The FDA approved Bizengri in late 2024 for the treatment of advanced, unresectable or metastatic NSCLC with a NRG1 gene fusion with disease progression on or after prior systemic therapy.

The effectiveness of Bizengri was shown 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, according to the agency.

As part of the “Speaking Out” video series, CURE® spoke with Andrew Ciupek, associate director of clinical research at GO2 for Lung Cancer, about the FDA’s approval of Bizengri, which he noted marks the first approval of a targeted therapy for this patient population.

“Bizengri is a targeted therapy, meaning that it specifically works by inhibiting a change or a mutation that causes the cancer to grow,” explained Ciupek. “So the way I like to describe it is in your normal lung cells, there are on/off switches that regulate and make sure that cells only grow when they're supposed to, like when there's an injury to the lung and they need the lung cells. But in cancer, those switches become permanently turned on in an incorrect way when they have changes to them, improper changes called mutations. So, a targeted therapy specifically targets that broken switch and tries to turn it back off again or prevent it from giving the signal to the cell to just grow all the time.”

Advancements such as these underscore the importance of patients undergoing biomarker testing in order to best tailor treatment strategies.

“When you're diagnosed, asking your doctor about receiving comprehensive biomarker testing,” Ciupek said. “[It] will set you up for the best treatment path, because it will tell you right away, do I have a change or a mutation for which there's an available targeted therapy that I could be started on? Or, you know, if I don't have one of those changes, we know we need to look at a different kind of treatment. So it's really important. I'd say the takeaway is that finding out whether you have an NRG1 fusion will tell whether you're a candidate for Bizengri or not, and that's true for any type of mutation. So, making sure you're asking your doctor about comprehensive biomarker testing is really important.”

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