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🔴 BreakingDrug approvalRSSFriday, May 8, 2026 · May 8, 2026

FDA Grants Seventh Approval under the National Priority Voucher Pilot Program

WHY IT MATTERS

Patients with NRG1 fusion-positive cholangiocarcinoma now have access to the first FDA-approved targeted treatment specifically designed for their genetic subtype of this ultra-rare cancer.

The FDA approved a new drug called Bizengri that treats a very rare and aggressive bile duct cancer called NRG1 fusion-positive cholangiocarcinoma. This approval is special because it's the seventh drug to receive fast-track approval through the FDA's National Priority Voucher Pilot Program, which helps speed up treatments for the rarest diseases. This cancer forms in the tubes that carry bile from the liver, and this new treatment targets a specific genetic change found in some patients with this disease.

FDA issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion-positive cholangiocarcinoma, an ultra-rare, aggressive cancer that forms in the bile ducts.

ASK YOUR DOCTOR

If you or a loved one has been diagnosed with NRG1 fusion-positive cholangiocarcinoma, ask your oncologist whether Bizengri (zenocutuzumab-zbco) is appropriate for your specific case and how to access it.

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