HER2 targeted dual-specific antibodies were identified by the FDA as breakthrough therapy for the treatment of specific bile duct cancer patients

Zymeworks announced today that the FDA has awarded its human skin growth factor subjectivity 2 (HER2) targeted dual-specific antibody zandatamab breakthrough therapy for the treatment of her2 gene amplification in patients with treated bile duct cancer (BTC).
breakthrough therapy identified zanidatamab's research and development process as more fda-directed and eligible for priority review and accelerated approval.
, including gallbladder and cholangiocarcinoma, account for about 3% of all adult cancers.
more than 210,000 people worldwide are diagnosed with BTC each year.
most BTC patients have tumors that cannot be surgically removed, and the recurrence rate is high in those who undergo potential root-and-drug surgery.
BTC patients with advanced disease progress after first-line chemotherapy had limited treatment options.
about 5% to 19% of BTC patients had tumor expression HER2, and tumor cells that expressed higher than normal levels of HER2 tended to grow faster and spread to other parts of the body.
these patients may potentially benefit from HER2 targeted treatment.
no HER2 targeted therapy has been approved for treatment of BTC.
Zanidatamab has a unique mechanism of action (Photo source: Resources) Zanidatamab is a dual-specific antibody that binds to both non-overlapping tables of HER2 at the same time.
This unique design creates a variety of mechanisms of action, including double HER2 signal blocking, increased removal of HER2 proteins from cell surfaces, and increased antibody-mediated cytotoxicity to produce encouraging anti-tumor activity in patients.
has entered into a research and development cooperation agreement with Zymeworks, which is exclusively licensed for the development and promotion of zandatamab in Asia (excluding Japan), Australia and New Zealand.
applications for clinical trials in China for this innovative therapy have also passed "implied approvals".
clinical trial data released by Zymeworks, zanidatamab, a single-drug therapy, achieved a 66.7 percent disease control rate when treating patients treated with her2 gene amplification.
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