FDA Greenlights Jazz Pharma's Cancer Drug, A Milestone For Zymework

On Wednesday, the FDA granted accelerated approval to Jazz Pharmaceuticals plc’s JAZZ Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use for adults with previously treated, unresectable, or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC).

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.

In late 2022, Zymeworks Inc JAZZ entered into a license and collaboration agreement with Jazz Pharmaceuticals 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 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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