Merus Gains FDA Approval for BIZENGRI® (Zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NSCLC
Thursday, December 05, 2024
Merus has announced that the United States Food and Drug Administration (FDA) has granted approval for BIZENGRI® (zenocutuzumab-zbco).
BIZENGRI® is a bispecific antibody targeting HER2 and HER3 receptors on cell surfaces, including tumour cells. It blocks HER2:HER3 dimerisation and NRG1 binding, disrupting key signalling pathways involved in cell proliferation.
The therapy also enhances antibody-dependent cellular cytotoxicity and has demonstrated antitumour activity in preclinical models of NRG1+ lung and pancreatic cancers.
BIZENGRI® is a bispecific antibody designed using Merus’s proprietary Biclonics® platform. It inhibits the dimerisation of HER2 and HER3, as well as the binding of NRG1 to HER3, thereby reducing tumour growth.
This is the first treatment approved for adult patients with advanced unresectable or metastatic pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) with neuregulin 1 (NRG1) gene fusion.
Approval was granted under the FDA’s accelerated approval programme based on data showing the treatment’s overall response rate (ORR) and duration of response (DOR). Continued approval will depend on further confirmation of clinical benefits in ongoing trials.
The FDA’s decision was based on results from the eNRGy trial, a multicentre, open-label study involving patients with NRG1+ pancreatic adenocarcinoma or NSCLC who had progressed following systemic therapy.
Among 30 patients with pancreatic adenocarcinoma, the ORR was 40%, with responses lasting between 3.7 and 16.6 months. For the 64 patients with NSCLC, an ORR of 33% was observed, with a median response duration of 7.4 months.
BIZENGRI® carries a boxed warning for embryo-foetal toxicity and other risks, including hypersensitivity reactions, interstitial lung disease, and left ventricular dysfunction.
Merus aims to facilitate access to BIZENGRI® through its PTx Assist™ programme, which provides educational resources, guidance on insurance coverage, and potential financial support. The treatment will be available in the coming weeks, with further prescribing details accessible online.
This approval is a significant step for patients with limited therapeutic options for NRG1+ cancers and highlights the potential of Merus’s Biclonics® technology in advancing oncology treatments.
Source: merus.nl
