FDA Grants Accelerated Approval to Merus’ Bizengri for NRG1+ Lung and Pancreatic Cancers

Approval Details:
The FDA has granted accelerated approval to Merus' Bizengri (zenocutuzumab-zbco) for the treatment of advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) and pancreatic adenocarcinoma that harbor NRG1 gene fusions and have disease progression on or after prior systemic therapy123.

Clinical Trial Results:
The approval is based on data from the eNRGy trial, which showed an overall response rate (ORR) of 33% in patients with NSCLC and 40% in patients with pancreatic adenocarcinoma. The median duration of response (DOR) was 7.4 months for NSCLC and ranged from 3.7 to 16.6 months for pancreatic adenocarcinoma123.

Availability:
Bizengri is expected to be available to patients in the coming weeks in the form of a 20mg/ml injection for intravenous use12.

Safety Information:
The drug carries a boxed warning for embryo-fetal toxicity and warnings for infusion-related reactions, hypersensitivity and anaphylactic reactions, interstitial lung disease/pneumonitis, and left ventricular dysfunction123.

Commercialization:
Merus has entered into an exclusive licensing agreement with Partner Therapeutics for the commercialization of Bizengri in the U.S.12.

Significance:
Bizengri is the first systemic therapy approved by the FDA specifically for NSCLC and pancreatic adenocarcinoma that harbor NRG1 gene fusions, addressing a significant unmet need for these patients123.

Sources:

1. https://www.clinicaltrialsarena.com/news/merus-bizengri-granted-fda-accelerated-approval-to-treat-nrg1-cancers/

2. https://ir.merus.nl/news-releases/news-release-details/merus-announces-fda-approval-bizengrir-zenocutuzumab-zbco-nrg1

3. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zenocutuzumab-zbco-non-small-cell-lung-cancer-and-pancreatic