On Dec. 4, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Bizengri (zenocutuzumab-zbco) for people with metastatic non-small cell lung cancer (NSCLC) who have an NRG1 mutation following progression on or after prior systemic therapy. Bizengri (zenocutuzumab-zbco) was also approved for the same group of people with metastatic pancreatic adenocarcinoma.

Bizengri (zenocutuzumab-zbco) is the first FDA-approved targeted therapy for people with NRG1-positive NSCLC. NRG1 mutations are considered rare in lung cancer, occurring in only around 0.2-0.3% of all NSCLC cases.

This latest approval is based on the results of the eNRGy study, which looked at treating people with metastatic NRG1-positive NSCLC with Bizengri (zenocutuzumab-zbco) following disease progression on standard-of-care treatment. Results showed that participants given Bizengri (zenocutuzumab-zbco) experienced a clinically meaningful response rate and duration of response to the targeted therapy.

Please speak with your healthcare team for more information about Bizengri (zenocutuzumab-zbco) to see if it may be a good option for you. If you have questions about treatment, trials, or biomarker testing, contact our LungMATCH team at support@go2.org or 1-800-298-2436.

Read the full FDA announcement.