FDA Approves Jazz Pharmaceuticals' Ziihera® for HER2-Positive Biliary Tract Cancer
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) has revealed that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Ziihera® (zanidatamab-hrii) at a concentration of 50mg/mL for intravenous administration, intended for the treatment of adult patients with previously treated, unresectable, or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as confirmed by an FDA-recognized test. The approval of Ziihera was based on an objective response rate (ORR) of 52% and a median duration of response (DOR) of 14.9 months, as assessed by independent central review (ICR). Ongoing approval for this treatment may depend on the confirmation and elucidation of clinical advantages in a subsequent trial. The Phase 3 HERIZON-BTC-302 confirmatory study is currently in progress to assess the effectiveness of zanidatamab combined with standard-of-care therapy as compared to standard-of-care therapy alone as a first-line treatment for patients with HER2-positive BTC.
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"Biliary tract cancer (BTC) is an aggressive malignancy characterized by a grim prognosis, with five-year survival rates falling below five percent in cases of metastasis. According to Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer at Jazz Pharmaceuticals, there is significant unmet medical need for patients suffering from unresectable or metastatic HER2-positive BTC, as treatment options have been severely limited with few therapies available.
The FDA's endorsement of Ziihera, which had previously received Breakthrough Therapy Designation, signifies a notable advancement, presenting the first and only bispecific antibody that targets dual HER2 without chemotherapy for BTC patients. We are eager to further explore zanidatamab in BTC and other solid tumors expressing HER2, aiming to enhance outcomes for individuals affected by these challenging HER2-positive cancers.
The FDA's decision to approve Ziihera rests on strong evidence from the HERIZON-BTC-01 clinical trial, which assessed zanidatamab as a monotherapy in previously treated HER2-positive BTC cases, as identified by Roche Diagnostic's PATHWAY® anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody companion diagnostic. This trial is noted as the largest Phase 2b study targeting this specific patient demographic.
The primary goal of the trial, which was to establish the confirmed objective response rate (cORR) via independent central review (ICR), was successfully met. The findings were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2023, published in The Lancet Oncology, and featured in the 2023 Best of ASCO® program. Additional follow-up data highlighting improvements in previously reported duration of response (DOR) were also shared at the ASCO Annual Meeting in 2024.
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According to the data provided by the Synapse Database, As of November 27, 2024, there are 740 investigational drugs for the HER2 target, including 350 indications, 740 R&D institutions involved, with related clinical trials reaching 3364, and as many as 77736 patents.
Zanidatamab is a bispecific antibody drug designed to target HER2. It has been developed for a wide range of therapeutic areas, including neoplasms, digestive system disorders, skin and musculoskeletal diseases, endocrinology and metabolic diseases, respiratory diseases, mouth and tooth diseases, and urogenital diseases.
