The U.S. Food and Drug Administration approved Ziihera (zanidatamab-hrii), developed by Zymeworks (ZYME, Financials), for the treatment of adults with previously treated, unresectable, or metastatic HER2-positive biliary tract cancer.
Independent central assessment revealed a 52% objective response rate and a median period of response of 14.9 months, which qualified the agency's fast approval procedure.
Approved initially in the United States for HER2-positive biliary tract cancer, Ziihera is a dual HER2-targeted bispecific antibody. Administered intravenously, the medication targets HER2-positive cancer cells utilizing a novel binding method that lowers receptor activation on the tumor cell surface, hence inducing tumor cell death.
Clinical-stage biotechnology startup Zymeworks signed a cooperation deal with Jazz Pharmaceuticals for the exclusive development and commercialization of Ziihera in most global markets, except some Asia-Pacific territory. Zymeworks will receive a $25 million milestone payment from Jazz after the FDA's ruling; further possible regulatory milestone payments up to $500 million and commercial milestones totaling $862.5 million. Additionally earning royalties ranging from 10% to 20% of net sales is the corporation.
Approved based on findings from the HERIZON-BTC-01 Phase 2b study, which assessed Ziihera as a single treatment for HER2-positive biliary tract cancer, The trial revealed consistent therapeutic benefits with its main target of objective response rate. As a first-line therapy, a Phase 3 confirmatory study is in progress evaluating Ziihera in concert with conventional medications.
To hasten its development and review procedures, Ziihera also holds regulatory classifications including Breakthrough Therapy and Orphan Drug status. In China and Europe, regulatory evaluations are in continuous progress.
Anticipated income from Ziihera will be used by Zymeworks to support their pipeline of medication candidates aimed at cancer and autoimmune illnesses. December will see the company's next R&D report, which will highlight developments on T cell engagers and novel antibody-drug conjugates.
