Key takeaways:
- The FDA approved Bizengri for adults with advanced, metastatic or unresectable NRG1 fusion-positive cholangiocarcinoma.
- Bizengri is the seventh drug approved under the National Priority Voucher pilot program.
The FDA has approved zenocutuzumab-zbco as the first drug for certain patients with a rare and aggressive bile duct cancer.
Zenocutuzumab-zbco (Bizengri, Partner Therapeutics) received approval for adults with advanced, metastatic or unresectable neuregulin 1 (NRG1) fusion-positive cholangiocarcinoma who experience disease progression during or after previous systemic therapy.
The FDA has approved the first drug for certain patients with a rare and aggressive bile duct cancer
Zenocutuzumab-zbco is the seventh drug to receive approval under the National Priority Voucher (CNPV) pilot program.
“Patients with this ultra-rare type of cancer desperately need new treatment options,” FDA Commissioner Marty Makary, MD, MPH, said in a press release. “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.”
The FDA based its approval on a single-arm trial that included 19 patients with NRG1 fusion-positive cholangiocarcinoma.
In that study, 36.8% of participants had an overall response, which lasted between 2.8 and 12.9 months.
Serious adverse events associated with zenocutuzumab-zbco include infusion-related reactions, interstitial lung disease and pneumonitis, and left ventricular dysfunction.
Other common adverse events include abdominal pain, constipation, diarrhea, dyspnea, edema, fatigue, musculoskeletal pain, nausea, rash, and vomiting.
Sources/Disclosures
Source:
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