Zenocutuzumab-zbco Granted FDA Breakthrough Therapy Designation for NRG1+ Cholangiocarcinoma
“In December 2024, zenocutuzumab-zbco (tradename BIZENGRI) received accelerated approval for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) and pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. The new data from the eNRGy trial highlight the potential of zenocutuzumab-zbco as a promising treatment option for patients with NRG1 fusion–positive cholangiocarcinoma,” said Pritesh J. Gandhi, PharmD, Chief Development Officer of Partner Therapeutics. “With the growing number of genomic alternations and gene fusions that are now actionable, it is imperative that oncologists order upfront tissue-based RNA next generation sequencing to ensure that gene fusions, of which NRG1 is just one, are not missed.”
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