Partner Therapeutics announced last week that the FDA had granted Bizengri a Commissioner’s National Priority Voucher to accelerate drug review.
The FDA has approved the use of Partner Therapeutics’ Bizengri to treat patients with cholangiocarcinoma carrying a specific genetic mutation—a decision that came just days after the drug was awarded the regulator’s national priority voucher.
Bizengri, a HER2- and HER3-directed bispecific antibody that received accelerated approval in December 2024 for certain adults with non-small cell lung cancer (NSCLC) and children with adenocarcinoma harboring an NRG1 gene fusion, is the seventh drug approval under the Commissioner’s National Priority Voucher (CNPV) program of the FDA, the regulator said in a Friday release.
With this latest approval, Bizengri can now be used in adults with cholangiocarcinoma positive for the NRG1 gene fusion, a key genetic alteration that leads to a deadlier disease and is found in fewer than 1% of all cholangiocarcinoma patients, according to a press announcement from Partner last Wednesday.
Bizengri is the first FDA-approved therapy for this particular type of cholangiocarcinoma and is specifically indicated for those whose disease has progressed on or after a previous line of systemic therapy, the FDA said.
Data from a single-arm study involving 19 patients formed the basis of Bizengri’s approval. Overall response rate was 36.8%, according to the FDA, with duration of response running from 2.8 months to 12.9 months.
“Through the national priority voucher pilot program, the FDA is accelerating therapies for rare diseases with unmet medical needs, reviewing applications in significantly shortened timelines,” Commissioner Marty Makary said in a prepared statement. Partner filed its supplemental application for Bizengri last month. The FDA awarded Bizengri its CNPV ticket publicly two days before securing the approval.
Unveiled in June 2025 and piloted a month later, the CNPV program rewards companies that align with certain federal priorities, including lowered drug prices and investments to onshore manufacturing capabilities. Vouchers drastically cut down FDA review times.
In the more than 10 months that it’s been in play, however, the CNPV program continues to be hounded by uncertainties and legal questions. “In theory, the benefits look great,” Kinnari Patel, CEO of think-tank RTW Institute, told BioSpace in an interview in March. Indeed, the CNPV program has led to the speedy approval of impactful drugs, such as Boehringer Ingelheim’s Hernexeos for unresectable or metastatic non-small cell lung cancer with certain mutations, as well as Eli Lilly’s weight-loss pill Foundayo.
Still, “the criteria for selection is not as transparent and standardized as we would like,” Patel told BioSpace, leaving companies in the dark about whether they could qualify for a voucher or not. In February, Rep. Jake Auchincloss (D-MA) raised similar transparency concerns, noting that the entire program has been “shrouded in secrecy,” with the FDA failing to respond to several Congressional inquiries.
Earlier this month, Sanofi reportedly asked to take its drug Tzield off the CNPV program after a high-level disagreement within the FDA over whether to grant approval for type 1 diabetes. Reviewers wanted to clear Tzield, but Tracy Beth Høeg, acting director of the Center for Drug Evaluation and Research, pushed back, citing uncertainties over the drug’s risk-benefit profile.
