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# Merus Zeno BLA Gets 3 Month Review Extension
- URL: https://www.fdaweb.com/merus-zeno-bla-gets-3-month-review-extension/
- Published: 2024-11-05T12:00:00.000Z
- Updated: 2026-09-14T14:46:09.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158123

FDA has extended by three months its priority review of a Merus BLA for Zeno (zenocutuzumab) for treating patients with neuregulin 1 fusion (NRG1+) non-small cell lung (NSCLC) and NRG1+ pancreatic (PDAC) cancer. The extension will give FDA additional time to review information recently submitted in response to a chemistry, manufacturing and controls information request, the company says, adding that no additional clinical data have been requested. The revised user fee review action target date is now 2/4/2025.

The NDA is based on data from [**the Phase 1/2 eNRGy trial (NCT02912949)**](https://www.cancernetwork.com/view/nrg1-solid-tumors-boast-impressive-responses-with-zenocutuzumab?ref=fdaweb.com) that is assessing the antitumor activity and safety of zenocutuzumab in patients with various *NRG1* fusion–positive solid tumors, including those with NSCLC or PDAC. The company earlier reported that treatment with zenocutuzumab showed an objective response rate of 34%, with target lesion reductions reported in 78% of patients. Additionally, the median duration of response was 12.9 months, with ongoing responses highlighted in 50% of patients at the time of the analysis.