(RTTNews) - Zymeworks (ZYME) announced, with Jazz Pharmaceuticals, that the 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. Ziihera, or zanidatamab-hrii, was approved under accelerated approval.
In late 2022, Zymeworks entered into a license and collaboration agreement with Jazz Pharmaceuticals Ireland 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. Under the terms of the Jazz license and collaboration agreement, Zymeworks has earned a milestone payment of $25 million based on the FDA approval in BTC. Zymeworks is also eligible to receive up to a further $500 million in regulatory milestone payments and $862.5 million in commercial milestone payments, as well as tiered royalties of 10% to 20% of net sales by Jazz.
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