FDA Approves BIZENGRI® for NRG1+ Cancer Therapy

The FDA has approved BIZENGRI® (zenocutuzumab-zbco), the first therapy specifically targeting neuregulin 1 (NRG1) gene fusions in advanced unresectable or metastatic pancreatic adenocarcinoma and non-small cell lung cancer (NSCLC). Developed by Merus N.V., this bispecific antibody offers a targeted option for patients who have progressed after prior systemic therapies.

BIZENGRI® works by binding to HER2 and HER3 receptors on cancer cells, disrupting critical signaling pathways that drive tumor growth. It also harnesses the immune system to attack cancer cells through antibody-dependent cellular cytotoxicity.

The approval is based on results from the eNRGy trial, which enrolled patients with NRG1+ cancers. Among patients with NRG1+ pancreatic adenocarcinoma, the overall response rate (ORR) was 40%, with responses lasting between 3.7 and 16.6 months. In NRG1+ NSCLC, the ORR was 33%, with a median duration of response (DOR) of 7.4 months. These outcomes reflect the therapy’s ability to achieve meaningful results in cancers with limited treatment options.

Uses and Administration
BIZENGRI® is indicated for adults with NRG1+ pancreatic adenocarcinoma or NSCLC that is advanced, unresectable, or metastatic and has progressed after systemic therapy. It is administered via intravenous infusion and requires monitoring during and after infusion for potential side effects.

Potential Side Effects
The most common side effects include diarrhea, fatigue, nausea, musculoskeletal pain, rash, and abdominal discomfort. Serious but less frequent adverse events include infusion-related reactions (13% of patients), interstitial lung disease (1.1%), and left ventricular dysfunction (2%). A boxed warning highlights risks of embryo-fetal toxicity, advising effective contraception for patients of reproductive potential during and after treatment.

A Milestone in Precision Medicine
Shannon Campbell, Chief Commercial Officer at Merus, described the approval as a testament to the company’s proprietary Biclonics® platform, which underpins BIZENGRI®’s development. Dr. Alison Schram of Memorial Sloan Kettering Cancer Center noted that the therapy has demonstrated clinically meaningful outcomes for patients with these rare genetic cancer drivers.

Merus, in partnership with Partner Therapeutics, plans to launch BIZENGRI® in the U.S. in the coming weeks. The company’s PTx Assist™ program will provide support for patients, including help navigating insurance coverage and financial assistance.

Read more: BIZENGRI. Prescribing information. Merus N.V.; 2024.