May 6 (Reuters) – Private biotech firm Partner Therapeutics said on Wednesday the U.S. Food and Drug Administration has granted a priority review voucher to its experimental bile duct cancer drug as part of a new fast-track review program.
• The antibody drug, Bizengri, is under review for adults with advanced cholangiocarcinoma whose tumors carry a rare genetic mutation and whose disease has worsened after prior treatment.
• Cholangiocarcinoma is a rare and aggressive cancer of the bile ducts. The genetic alteration, called NRG1 gene fusions, occurs in fewer than 1% of such cancer cases, and there is currently no approved targeted therapy for these patients, the company said.
• Launched in June 2025, the FDA commissioner’s National Priority Voucher (CNPV) pilot program is designed to shorten review time from the usual 10 to 12 months to as little as one to two months for drugs addressing major U.S. health priorities and unmet medical needs.
• Including Partner’s voucher, the regulator has granted 22 CNPV vouchers so far, of which six drugs have been approved.
• Partner’s application was based on mid-stage study data showing tumors shrank in more than one-third of evaluable patients, who lived for over nine months without the disease worsening.
• The drug is already approved for certain adults with advanced lung and pancreatic cancers whose disease has progressed after prior treatment.
(Reporting by Kunal Das in Bengaluru; Editing by Maju Samuel)
