Delhi, Nov. 25, 2024 (GLOBE NEWSWIRE) -- In November 2024, Jazz Pharmaceuticals announced that the US FDA granted accelerated approval for zanidatamab, a bispecific antibody, for the treatment of biliary tract cancer (BTC). This milestone is significant, as zanidatamab, now marketed under the name Ziihera, becomes the first and only dual HER2-targeted bispecific antibody approved for HER2-positive BTC in the US. Ziihera is specifically indicated for adult patients with unresectable or metastatic HER2-positive BTC who are treatment-naive. This approval underscores the growing importance of bispecific antibodies in cancer treatment and marks a major achievement in the development of innovative therapies for difficult-to-treat cancers like BTC.
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Ziihera’s approval is based on data from the HERIZON-BTC-01 clinical trial, which evaluated zanidatamab as a single agent in patients with previously treated HER2-positive BTC. The study reported promising results, including a 52% objective response rate (ORR) and a median duration of response (DOR) of 14.9 months. These results position Ziihera as a highly effective option for patients with this aggressive and challenging cancer type. The trial’s success is a testament to the potential of bispecific antibodies to target specific cancer markers, offering new hope to patients who otherwise have limited treatment options. The FDA’s accelerated approval process enables earlier access to promising therapies, though continued approval for Ziihera will depend on the outcome of ongoing confirmatory trials, including the Phase 3 HERIZON-BTC-302 trial, which is testing zanidatamab in combination with standard-of-care therapy for first-line treatment of HER2-positive BTC.
Ziihera is part of a broader trend in the development and approval of bispecific antibodies. These innovative therapies, which are designed to simultaneously target two different antigens, have gained increasing attention in oncology. By leveraging the strengths of monoclonal antibodies—proven in cancer treatments like trastuzumab (Herceptin)—bispecific antibodies offer a novel approach to targeting cancer cells more precisely and effectively. Ziihera, specifically designed to target two epitopes on the HER2 receptor, is an example of how bispecific antibodies are evolving to address specific needs in cancer therapy, particularly for hard-to-treat cancers like BTC.
The approval of Ziihera contributes to the growing number of bispecific antibodies on the market, with Ziihera becoming the 15th approved bispecific antibody as of late 2024. This growing class of therapies is revolutionizing cancer treatment, with bispecific antibodies now playing a critical role in managing various cancer types. The commercial success of bispecific antibodies is evident from their significant sales growth by mid-2024, sales of approved bispecific antibodies had surpassed US$ 5.5 billion, and projections indicate that by 2029, sales could exceed US$ 40 billion. This financial success highlights the growing recognition of bispecific antibodies as a valuable class of therapeutics with the potential to transform the oncology landscape.
