{"id":15060,"date":"2024-11-26T18:23:57","date_gmt":"2024-11-26T10:23:57","guid":{"rendered":"https:\/\/flcube.com\/?p=15060"},"modified":"2025-01-06T18:14:25","modified_gmt":"2025-01-06T10:14:25","slug":"zymeworks-and-jazz-pharmaceuticals-ziihera-gets-green-light-for-her2-btc-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=15060","title":{"rendered":"Zymeworks and Jazz Pharmaceuticals’ Ziihera Gets Green Light for HER2+ BTC Treatment"},"content":{"rendered":"\n

Partners Zymeworks Inc. (NASDAQ: ZYME<\/a>) and Jazz Pharmaceuticals, Inc. have received accelerated approval from the US Food and Drug Administration (FDA) for Ziihera (zanidatamab), a treatment for adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC). This marks a significant advancement in the treatment options for patients with this aggressive form of cancer.<\/p>\n\n\n\n

Roche’s PATHWAY Test Approved as Companion Diagnostic<\/strong>
A few days following the approval of Ziihera, Roche (SWX: ROG<\/a>) announced that the FDA had approved its PATHWAY anti-HER2\/neu (4B5) rabbit monoclonal primary antibody test as the first and only companion diagnostic (CDx) to aid in the assessment of HER2-positive status in identifying BTC patients eligible for treatment with Ziihera.<\/p>\n\n\n\n

Clinical Data Supporting Ziihera’s Approval<\/strong>
The accelerated approval for Ziihera, a bispecific HER2-directed antibody binding to two extracellular sites on HER2, was supported by a 52% objective response rate (ORR) and a median duration of response (DOR) of 14.9 months as determined by independent central review (ICR). These data underscore the potential impact of Ziihera on patient outcomes in HER2-positive BTC.<\/p>\n\n\n\n

Commercialization Rights and Financial Implications<\/strong>
China-based BeiGene (SHA: 688235<\/a>, HKG: 6160<\/a>, NASDAQ: BGNE<\/a>) secured development and commercial rights to Zymeworks\u2019 Ziihera through a 2018 deal, with an upfront payment of USD 53 million. In late 2022, Zymeworks granted Jazz rights to the drug in the US, Europe, Japan, and all other territories except for those Asia Pacific territories previously licensed by Zymeworks. As part of this agreement, Zymeworks has earned a milestone payment of USD 25 million based on the FDA approval in BTC. Zymeworks is also eligible to receive up to a further USD 500 million in regulatory milestone payments and USD 862.5 million in commercial milestone payments, as well as tiered royalties of 10% to 20% of net sales by Jazz.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Partners Zymeworks Inc. 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