JAZZ PHARMACEUTICALS FRANCE

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FDA approves Zihera, a non-chemotherapy treatment for metastatic HER2-positive biliary tract cancer, developed by Zymeworks. Jazz Pharmaceuticals secured commercialization rights for $375 million USD upfront, with additional royalties. Zihera showed significant tumor shrinkage in a Phase 2b trial, with benefits lasting an average of 15 months.

The FDA approved zanidatamab (Ziihera) for advanced HER2-positive biliary tract cancer, targeting HER2 at two sites to halt tumor growth and aid immune response. A companion diagnostic, Ventana Pathway anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody, was also approved. In a trial, 52% of patients saw tumor shrinkage for about 15 months. Ziihera carries a warning about potential harm to unborn babies and common side effects include diarrhea, infusion-related reactions, stomachache, and tiredness. Jazz Pharmaceuticals is testing Ziihera with standard therapy against standard therapy alone for first-line treatment.

Jazz Pharmaceuticals announced FDA accelerated approval of Ziihera (zanidatamab-hrii) for treating previously treated, unresectable or metastatic HER2-positive biliary tract cancer. Ziihera, a dual HER2-targeted bispecific antibody, demonstrated a 52% objective response rate and a median duration of response of 14.9 months. Continued approval may depend on results from the ongoing phase 3 HERIZON-BTC-302 trial. The approval addresses a significant unmet need for effective therapies in this patient population.

Jazz Pharmaceuticals' HER2-directed bispecific antibody Ziihera gains FDA approval for biliary tract cancer (BTC), with potential for broader indications like HER2-positive breast and gastric cancers. The approval is based on a 52% objective response rate in the HERIZON-BTC-01 trial, with Jazz aiming for peak sales of $2 billion. The company is also conducting phase 3 trials in gastroesophageal adenocarcinoma and breast cancer.

Ziihera, a dual HER2-targeted bispecific antibody, received accelerated FDA approval for treating previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC) with a 52% objective response rate and median duration of response of 14.9 months. Continued approval may depend on results from the ongoing Phase 3 HERIZON-BTC-302 trial.

Zymeworks and Jazz Pharmaceuticals receive FDA accelerated approval for Ziihera (zanidatamab-hrii) in treating HER2-positive biliary tract cancer (BTC). Ziihera, a dual HER2-targeted bispecific antibody, is the first chemotherapy-free treatment for BTC. Zymeworks earns $25m milestone payment and is eligible for up to $1.3625b in milestones and royalties. FDA approval supported by HERIZON-BTC-01 trial data, showing 52% objective response rate and 14.9 months median duration of response.

FDA grants accelerated approval to zanidatamab for pretreated HER2-positive biliary tract cancer, with HER2 positivity defined as IHC score of 3+. HERIZON-BTC-01 trial showed 52% response rate, 14.9 months duration of response. Ongoing phase III trial HERIZON-BTC-302 to confirm benefit. Common AEs include diarrhea, infusion-related reactions, abdominal pain, and fatigue.

The FDA granted accelerated approval to Zymeworks Inc.'s Ziihera for treating biliary tract cancer, triggering a $25M milestone payment from Jazz Pharmaceuticals. Zymeworks could earn over $1B in milestone payments and royalties. Ziihera is a variation of Zanidatamab, developed for various cancers, and marks Zymeworks' first FDA-approved therapy.

Zymeworks and Jazz Pharmaceuticals announce FDA accelerated approval of Ziihera 50mg/mL for HER2-positive biliary tract cancer, with a 52% response rate and 14.9-month median duration. Zymeworks earned $25M milestone and may receive up to $1.362B more in payments and royalties.