Saturday, June 22, 2024

Biliary Tract Cancer: FDA Grants Priority Review to Jazz Pharmaceuticals’ Zanidatamab for HER-2 Positive Forms

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Biliary tract cancer treatment has taken a significant step forward as Jazz Pharmaceuticals announced that the US Food and Drug Administration (FDA) has granted Priority Review status to zanidatamab, a bispecific antibody under evaluation for patients with previously treated, unresectable, locally advanced, or metastatic HER2-positive BTC.

The submission was based on promising results from Cohort 1 of the Phase IIb HERIZON-BTC-01 clinical trial, which demonstrated a confirmed objective response rate (cORR) of 41.3%. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 29, 2024, for this application.

Biliary Tract Cancer: Zanidatamab Shows Promise as New Treatment for HER2-Positive Cases

The HERIZON-BTC-01 trial provided critical data supporting the potential of zanidatamab as a treatment for HER2-positive BTC, a condition with a dire prognosis. Dr. Rob Iannone, Executive Vice President and Global Head of Research and Development at Jazz Pharmaceuticals, emphasized the significance of this development in a press release, stating, “The priority review designation for zanidatamab underscores the critical need for new treatment options for patients with locally advanced or metastatic HER2-positive BTC, a devastating disease with a poor prognosis. Upon approval, zanidatamab will be the first HER2-targeted treatment specifically indicated for these patients, and we look forward to the opportunity to deliver this new treatment option to the BTC community.”

In addition to the Phase IIb trial, a Phase III trial, HERIZON-BTC-302, is currently underway. This trial aims to evaluate the efficacy of zanidatamab in combination with standard-of-care therapy compared to standard-of-care therapy alone in first-line treatment for advanced or metastatic HER2-positive BTC.

Biliary Tract Cancer

Biliary Tract Cancer: Zanidatamab’s Biologics License Application Seeks Accelerated FDA Approval Based on Promising Trial Data

The Biologics License Application (BLA) for zanidatamab, submitted to the FDA in April, seeks accelerated approval based on the robust data from the Phase IIb HERIZON-BTC-01 trial. The trial’s findings revealed a median duration of response of 12.9 months [95% CI: 6.0-not estimable], a significant improvement over the historically low response rates of 5% to 15% typically seen with chemotherapy in BTC patients.

Dr. Iannone further commented on the potential impact of zanidatamab, stating, “This important milestone brings us one step closer to delivering zanidatamab, a targeted treatment option, to patients living with HER2-positive BTC, a type of cancer that is associated with a five-year overall survival rate of less than 5%. Zanidatamab is a biparatopic HER2-targeted bispecific antibody that simultaneously binds two non-overlapping epitopes of HER2 resulting in multiple mechanisms of action. Second-line (2L) BTC represents the first of multiple indications we are evaluating, and we are excited about zanidatamab’s potential as a new option for multiple HER2-expressing cancers, with ongoing Phase III trials in 1L BTC, 1L gastroesophageal adenocarcinoma, and previously treated breast cancer.”

The American Cancer Society reports that bile duct cancers are particularly challenging to diagnose, with an estimated 8,000 new cases in the US each year. However, the actual number might be higher due to diagnostic difficulties. Survival rates for bile duct cancer depend on factors such as the patient’s age, the cancer stage at diagnosis, and its exact location. Typically, bile duct cancer is diagnosed in older adults, with an average age of 70 for intrahepatic bile duct cancer and 72 for extrahepatic bile duct cancer.

Zanidatamab’s development and potential approval represent a significant advancement for patients with HER2-positive BTC, providing hope for improved treatment outcomes. The ongoing research and trials reflect Jazz Pharmaceuticals’ commitment to addressing the unmet needs in oncology, particularly for cancers with historically poor prognoses. With the FDA’s Priority Review designation, zanidatamab could soon become the first HER2-targeted therapy available for this challenging cancer, offering new hope to patients and their families.

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Resource: Jazz Pharmaceutical, May 30, 2024

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