Ziihera was approved under accelerated approval based on a 52% objective response rate (ORR) and a median duration of response (DOR) of 14.9 months.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Also Read: Jazz Pharmaceuticals’ Zepzelca/Tecentriq Combo Regimen Can Potentially Delay Disease Progression, Extend Survival In Aggressive Form Of Lung Cancer

The Phase 3 HERIZON-BTC-302 confirmatory trial is ongoing to evaluate zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone in the first-line setting for patients with HER2-positive BTC.

Regulatory reviews of zanidatamab for BTC remain ongoing in China and Europe.

Under the Jazz license and collaboration agreement terms, 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.

Zymeworks says the approval represents the first FDA-approved therapy in its pipeline and validates the company’s Azymetric bispecific platform technology.

Price Action: JAZZ stock closed at $119.24 on Wednesday.

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