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# FDA Fast Track for Alphamab Cancer Drug
- URL: https://www.fdaweb.com/fda-fast-track-for-alphamab-cancer-drug/
- Published: 2025-10-30T12:00:00.000Z
- Updated: 2026-09-14T15:25:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160137

FDA has granted a fast-track designation for Alphamab Oncology’s biparatopic HER2-targeting antibody drug conjugate JSKN003 to treat advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, not restricted by HER2 expression. A company [statement](https://www.prnewswire.com/apac/news-releases/alphamab-oncology-announces-biparatopic-her2-targeting-adc-jskn003-was-granted-fast-track-designation-by-fda-for-the-treatment-of-proc-302596008.html?ref=fdaweb.com) says the designation follows FDA approval earlier this year of an orphan drug designation for gastric cancer/gastroesophageal junction cancer.

The statement says JSKN003 is developed by site-specific conjugation to the Fc glycans of anbenitamab, resulting in a homogenous and stable antibody-drug conjugate with a drug-to-antibody ratio of 4\. JSKN003 binds to two HER2 epitopes on tumor cells and releases topoisomerase 1 inhibitors through cellular endocytosis, exerting anti-tumor effects, it says.