Zymeworks, Jazz Pharmaceuticals announce FDA approval of Ziihera

Zymeworks (ZYME) announced, with Jazz Pharmaceuticals (JAZZ), that the U.S. FDA has granted accelerated approval of Ziihera 50mg/mL for injection for intravenous use for the treatment of adults with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer, as detected by an FDA-approved test. Ziihera was approved under accelerated approval based on a 52% objective response rate and a median duration of response of 14.9 months as determined by independent central review. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1 The approval of Ziihera, which previously received Breakthrough Therapy Designation from the FDA for this indication, is an important advance and offers the first and only dual HER2-targeted bispecific antibody and chemotherapy-free treatment for patients living with BTC. In late 2022, Zymeworks entered into a license and collaboration agreement with Jazz Pharmaceuticals Ireland Limited, for the exclusive development and commercialization rights to zanidatamab across all indications in the United States, Europe, Japan and all other territories except for those Asia Pacific territories previously licensed by Zymeworks. This collaboration allowed the company to leverage Jazz’s global commercial infrastructure, together with BeiGene’s complementary strengths in certain Asia Pacific countries, to enable the global, rapid advancement of zanidatamab in multiple tumor types with the potential to provide a foundational HER2-targeted therapy for patients with difficult-to-treat cancers and limited treatment options. Under the terms of the Jazz license and collaboration agreement, Zymeworks has earned a milestone payment of $25M based on the FDA approval in BTC. Zymeworks is also eligible to receive up to a further $500M in regulatory milestone payments and $862.5M in commercial milestone payments, as well as tiered royalties of 10% to 20% of net sales by Jazz.