Out of nowhere comes a super-fast Bizengri approval

Sales of Partner Therapeutics’ anti-HER-2 x HER-3 bispecific Bizengri won’t set the world on fire any time soon, but the drug’s latest approval caught everyone by surprise. The US nod, for relapsed NRG1 fusion-positive cholangiocarcinoma, came on Friday – just two days after the drug's US commissioner’s national priority voucher (CNPV) award was announced. It’s not clear whether Partner had applied for a CNPV, or whether, like for Johnson & Johnson’s Tecvayli, the FDA awarded one proactively, and nothing has been revealed about the review process. The PDUFA date was apparently in October, and to get a drug approved in the space of two days is a record for the CNPV scheme, whose aim is to cut review time from 10-12 months to one or two months; CNPV-based oncology approvals have so far taken around three months. Bizengri holds previous accelerated approvals in pancreatic and non-small cell lung cancers with NRG1 fusions, a tiny treatment niche, but the latest nod is a full green light. In December 2024 Partner gained commercialisation rights to Bizengri from Merus for an undisclosed fee. The CNPV scheme has come under fire over claims that it’s being used as a tool to curry political favour. CNPVs awarded in oncologyDrugCompanyIndicationCNPV awardedUS approvedBizengriPartner (ex Merus)2nd-line NRG1 fusion+ve cholangiocarcinoma6 May 20268 May 2026TevayliJohnson & Johnson2nd-line multiple myeloma, Darzalex Faspro combo15 Dec 2025*5 Mar 2026HernexeosBoehringer Ingelheim1st-line HER2m NSCLC6 Nov 202526 Feb 2026Sacituzumab tirumotecanMerck & Co/ KelunUndisclosed19 Dec 2025NA (and no filing disclosed)JemperliGSKRectal cancer6 Nov 2025NA (and no filing disclosed)DaraxonrasibRevolutionPancreatic cancer16 Oct 2025NA (and no filing disclosed)Note: *award was made “proactively” by the FDA. Source: OncologyPipeline.