By VETTAPHARMA reporter – Derek Roche: U.S. Food and Drug Administration granted the seventh approval under the National Priority Voucher Pilot Program, approving Bizengri (zenocutuzumab-zbco) for patients with NRG1 fusion-positive cholangiocarcinoma whose disease progressed following prior systemic therapy.
The approval was supported by data from the Phase 1/2 eNRGy trial (NCT02912949), which evaluated zenocutuzumab in patients with NRG1 fusion-positive solid tumors. The study demonstrated an overall response rate of 36.8%, with response durations ranging from 2.8 to 12.9 months in treated patients.
The National Priority Voucher Pilot Program was launched to accelerate review timelines for products aligned with critical US health priorities, using a collaborative review model intended to shorten regulatory evaluation timelines while maintaining existing approval standards.
This latest approval reflects the FDA’s broader strategy of combining accelerated regulatory pathways, targeted oncology innovation, and AI-enabled review modernization to support faster access to therapies addressing serious and rare diseases.
For patients with NRG1 fusion-positive cholangiocarcinoma, a rare and difficult-to-treat bile duct cancer, the approval introduces a targeted treatment option in a setting with limited therapeutic alternatives. Accelerated review under the voucher programme may also contribute to earlier patient access to innovative therapies in future oncology indications.
From an industry perspective, the continued expansion of the National Priority Voucher Pilot Program may encourage additional investment in rare diseases, precision oncology, and high-priority therapeutic areas, particularly where accelerated regulatory pathways can reduce time to market.
