Admin_Adham
The FDA has approved zenocutuzumab (BIZENGRI, Partner Therapeutics) for adults with advanced, unresectable, or metastatic cholangiocarcinoma harboring an NRG1 gene fusion following progression on or after prior systemic therapy.
The approval came just 2 days after Partner announced zenocutuzumab was fast-tracked for approval under the FDA’s Commissioner’s National Priority Review Voucher pilot program, which aims to “dramatically reduce” review times.
NRG1 gene fusions are rare oncogenic drivers. Zenocutuzumab is a first-in-class bispecific antibody targeting the fusions, which are found in less than 1% of cholangiocarcinoma cases. The agent was previously granted accelerated approval for advanced, unresectable, or metastatic non-small cell lung and pancreatic adenocarcinoma harboring NRG1 gene fusions.
Approval for the cholangiocarcinoma indication was based on 19 adults enrolled in the open-label eNRGy trial. The overall response rate was 36.8%, with durations of response ranging from 2.8 to 12.9 months.
The most common adverse events included diarrhea, musculoskeletal pain, fatigue, nausea, infusion-related reactions, dyspnea, rash, constipation, vomiting, abdominal pain, and edema.
Labeling warns of infusion-related reactions, hypersensitivity, anaphylactic reactions, interstitial lung disease or pneumonitis, left ventricular dysfunction, and embryo-fetal toxicity.
The recommended zenocutuzumab dose is 750 mg administered intravenously every 2 weeks until disease progression or unacceptable toxicity.
M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@medscape.net
