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Jazz Pharmaceuticals' Ziihera® Approved by NCCN Guidelines for Biliary Tract Cancer

On December 5, 2024, Jazz Pharmaceuticals plc announced a significant development in cancer treatment with the inclusion of their therapy, zanidatamab-hrii (branded as Ziihera®), in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology. This endorsement recognizes Ziihera as a category 2A treatment option for biliary tract cancers (BTC), making it a critical component in the fight against this severe disease.

Ziihera has gained attention as the first FDA-approved dual HER2-targeted bispecific antibody for patients diagnosed with HER2-positive biliary tract cancers. It is now available in the United States for intravenous use at a concentration of 50 mg/mL. This key approval was granted following the promising results of the HERIZON-BTC-01 clinical trial, which demonstrated a robust 52% objective response rate along with a median duration of response extending to 14.9 months. However, it's important to note that the continued approval might depend on further validation of the clinical benefits in upcoming confirmatory trials.

Rob Iannone, M.D., M.S.C.E., Executive Vice President and Chief Medical Officer at Jazz Pharmaceuticals, expressed enthusiasm over the inclusion of Ziihera in the NCCN guidelines. He emphasized the importance of expanding treatment options for patients suffering from this challenging malignancy. "Ziihera is the first and only bispecific antibody that targets HER2 and provides a chemotherapy-free alternative for patients living with biliary tract cancer, which historically has had limited therapeutic options," he said.

The NCCN Guidelines play an essential role in global cancer treatment decision-making, offering comprehensive recommendations for oncologists, nurses, pharmacists, and patients. These guidelines assist in selecting appropriate cancer management strategies, ultimately striving for better patient outcomes.

Biliary tract cancer, comprising gallbladder cancer and cholangiocarcinoma, constitutes less than 1% of all adult cancers globally. Patients diagnosed with HER2-positive BTC often face a grim prognosis due to the insufficient treatment options available. In the United States alone, approximately 12,000 patients are affected by HER2-positive biliary tract cancer each year.

The generation of novel cancer therapies is essential in addressing the unmet needs of patients battling severe forms of cancer. The development of Ziihera underscores Jazz Pharmaceuticals’ commitment to advancing oncology strategies that could potentially enhance the quality of life for patients with limited treatment alternatives.

As an innovative biopharma company, Jazz Pharmaceuticals is dedicated to transforming the lives of patients grappling with serious conditions – particularly those facing severe diseases with few therapeutic choices. Their portfolio incorporates not only sleep disorder and epilepsy treatments but also a growing selection of therapies targeting various cancers, demonstrating their comprehensive approach to healthcare.

For more information about Ziihera, including its prescribing information and indications, please visit the official Jazz Pharmaceuticals website. The latest advancements in cancer treatment illustrate the ongoing commitment to improving patient care and oncological outcomes in the face of challenging diseases.

Jazz Pharmaceuticals continues to pursue groundbreaking research and development to unlock novel therapeutic options for cancer patients around the world. Their efforts represent a beacon of hope amidst the complexities of cancer treatment, reaffirming the importance of innovative therapies like Ziihera in the oncology landscape.