Zymeworks Inc., in collaboration with Jazz Pharmaceuticals, announced on November 21, 2024, that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Ziihera (zanidatamab-hrii) for the treatment of adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC). This approval marks Ziihera as the first and only dual HER2-targeted bispecific antibody and chemotherapy-free treatment for this indication.
The accelerated approval was based on compelling data from the HERIZON-BTC-01 trial, which demonstrated an objective response rate (ORR) of 52% and a median duration of response (DOR) of 14.9 months, as determined by independent central review. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.
Under the terms of its license and collaboration agreement with Jazz Pharmaceuticals, Zymeworks has earned a $25 million milestone payment due to this FDA approval. The company is also eligible to receive up to an additional $500 million in regulatory milestone payments and $862.5 million in commercial milestone payments, along with tiered royalties ranging from 10% to 20% of net sales by Jazz. This approval validates Zymeworks' Azymetric bispecific platform technology and its internal research and development capabilities.
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