FX.co ★ FDA Grants Accelerated Approval For Merus' BIZENGRI For Pancreatic Adenocarcinoma And NSCLC

Merus N.V. (MRUS) has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to BIZENGRI (zenocutuzumab-zbco). This medication marks a significant milestone as the first and only treatment available for adults with advanced unresectable or metastatic pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) associated with a neuregulin 1 (NRG1) gene fusion. This approval specifically targets patients whose disease has progressed despite previous systemic therapies.

Future continued approval for these uses may rely on the confirmation and demonstration of clinical benefit in further confirmatory trial(s).

BIZENGRI carries a Boxed WARNING for Embryo-Fetal Toxicity. Additionally, there are warnings for potential infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions, interstitial lung disease (ILD)/pneumonitis, and left ventricular dysfunction.

BIZENGRI (zenocutuzumab-zbco), delivered as a 20 mg/mL injection for intravenous use, is anticipated to become available to patients within the coming weeks.