The FDA’s seventh approval under its pilot program highlights the agency’s ability to accelerate drug reviews through the U.S. national priority initiative.
On Friday, just two days after awarding Partner Therapeutics a Commissioner’s National Priority Voucher (CNPV), the FDA gave the nod to Bizengri as a second-line treatment for adults with severe, unresectable or metastatic cholangiocarcinoma carrying an NRG1 gene fusion.
The authorization marks the third approved use for Bizengri, which previously received first-in-class accelerated approvals in late 2024 for NRG1-positive pancreatic adenocarcinoma and non-small cell lung cancer. Partner Therapeutics secured U.S. rights to the bispecific antibody from Merus shortly after the drug’s initial approval.
The cholangiocarcinoma clearance also represents another rapid approval under the FDA’s CNPV pilot, introduced last June. The initiative is designed to shorten review timelines to one or two months, compared with the standard 10- to 12-month review process, for therapies considered aligned with U.S. national priorities. Other companies benefiting from the program include Novo Nordisk, J&J as well as Boehringer Ingelheim.
FDA Commissioner Marty Makary said in a statement released Friday that patients with this very rare form of cancer urgently need additional treatment choices. He added that the national priority voucher pilot is helping the FDA speed up reviews for therapies targeting rare diseases with unmet medical needs by significantly compressing review timelines.
Before obtaining the CNPV, Bizengri had already received FDA breakthrough therapy and orphan drug designations for cholangiocarcinoma, according to Partner Therapeutics. The company announced its supplemental FDA filing for the expanded indication on April 14.
The latest approval was supported by findings from the midstage eNRGy trial study, which enrolled 22 patients, with 19 considered evaluable for efficacy. Results showed that nearly 37% of cholangiocarcinoma patients responded to treatment, with response durations ranging from 2.8 months to just under 13 months.
Pritesh Gandhi said the data demonstrated meaningful tumor shrinkage, durable clinical benefit and a manageable safety profile, while also noting that the FDA’s CNPV pilot substantially reduced review time and accelerated patient access to the therapy.
Cholangiocarcinoma is an uncommon and aggressive bile duct cancer with an overall five-year survival rate below 15% across all stages, according to Partner Therapeutics. The NRG1 gene fusions targeted under Bizengri’s updated label occur in less than 1% of cholangiocarcinoma cases and are often found in younger adults lacking other driver mutations, leaving them without approved targeted treatment options.
Although seven therapies have now been approved through the CNPV pathway, the initiative has also faced criticism. Lawmakers expressed concerns last year that the program could be susceptible to favoritism or political influence benefiting drugmakers connected to the Trump administration. Critics have additionally warned that accelerated timelines may compromise the FDA’s regulatory rigor and result in overly rushed reviews.
The FDA has scheduled a public hearing for June 4 to gather feedback on the program and is specifically requesting comments on eligibility standards, sponsor obligations, selection procedures, submission requirements and review processes.
Bizengri Secures FDA Approval for Cancer Treatment Expansion
Partner Therapeutics announced that Bizengri has received approval from the U.S. Food and Drug Administration, marking an important milestone for the company’s oncology portfolio. The approval strengthens the company’s presence in cancer treatment innovation and opens new opportunities within the healthcare market.
The FDA decision highlights growing demand for advanced therapies designed to improve treatment outcomes for patients facing complex cancers. Industry analysts believe the approval could enhance commercial growth opportunities while increasing competition within the oncology sector.
Bizengri Expands Oncology Treatment Options
The approval of Bizengri reflects continued progress in targeted cancer therapies and precision medicine. Pharmaceutical companies are increasingly focusing on treatments that offer more effective and personalized approaches for cancer patients.
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