FDA grants Commissioner’s National Priority Voucher to Partner Therapeutics’ BIZENGRI for NRG1+ cholangiocarcinoma, supporting accelerated review of the investigational bispecific antibody following encouraging Phase 2 eNRGy trial data.
Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
Partner Therapeutics announced that the U.S. Food and Drug Administration (FDA) has awarded a Commissioner’s National Priority Voucher (CNPV) for BIZENGRI® (zenocutuzumab-zbco) for the treatment of adults with advanced, unresectable, or metastatic cholangiocarcinoma harboring neuregulin 1 (NRG1) gene fusions with disease progression on or after prior systemic therapy.
The company submitted a supplemental Biologics License Application (sBLA) to the FDA for this indication based on data from the Phase 2 eNRGy trial (NCT02912949). BIZENGRI previously received Breakthrough Therapy Designation and Orphan Drug Designation from the FDA for NRG1-positive cholangiocarcinoma.
According to Partner Therapeutics Chief Development Officer Pritesh J. Gandhi, the voucher reflects FDA recognition of the significant unmet need in patients with NRG1-positive cholangiocarcinoma, an ultra-rare cancer subtype with no approved targeted therapies currently available. He noted that data from the eNRGy trial showed meaningful tumor responses, durable clinical benefit, and a favorable tolerability profile, supporting the potential of BIZENGRI to address an important treatment gap.
The FDA launched the Commissioner’s National Priority Voucher pilot program in June 2025 to accelerate review timelines for therapies addressing national health priorities. Under the initiative, review times may be reduced from the standard 10–12 months to as little as 1–2 months for products demonstrating innovative mechanisms and the potential to address major unmet medical needs. The program uses a multidisciplinary review model involving FDA review teams and senior agency leadership.
BIZENGRI is a first-in-class bispecific antibody designed to inhibit HER2/HER3 signaling driven by NRG1 gene fusions. NRG1 fusions are rare oncogenic drivers that activate HER2/HER3 pathways and promote tumor growth. Zenocutuzumab-zbco works by blocking HER2/HER3 dimerization and preventing NRG1 fusion interactions with HER3, thereby suppressing downstream signaling pathways associated with cancer cell proliferation.
Stacie Lindsey CEO, Cholangiocarcinoma Foundation emphasized that earlier diagnosis and broader biomarker testing are important for identifying patients with NRG1-positive cholangiocarcinoma who may benefit from emerging targeted therapies.
Clinical findings from the cholangiocarcinoma cohort of the Phase 2 eNRGy trial were presented at the AACR-NCI-EORTC Meeting in October 2025.
According to Alison Schram Principal Investigator of the eNRGy trial zenocutuzumab demonstrated objective responses in more than one-third of evaluable patients, with median progression-free survival exceeding nine months. She also highlighted the importance of comprehensive molecular profiling, particularly RNA-based testing, to identify patients with actionable NRG1 fusions who may benefit from targeted treatment approaches.
Cholangiocarcinoma is a rare and aggressive bile duct cancer with limited second-line treatment options, while NRG1 gene fusions occur in fewer than 1% of cases and currently lack approved targeted therapies.
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About the Writer
Nikita Jha, BPharm a pharmacy graduate specializing in medical writing, with a strong ability to interpret complex medical and regulatory information and translate it into clear, accurate, and evidence-based healthcare content. Known for her attention to detail and precision, she focuses on delivering high-quality scientific communication that supports drug safety and informed decision-making.