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Zymeworks' therapy for stomach cancer gets US FDA fast-track status

The U.S. Food and Drug Administration granted fast-track designation Zymeworks Inc.'s bispecific antibody as initial treatment for a type of stomach cancer.

The fast-track designation expedites the review process for drugs that address a condition with a high, unmet need.

Zymeworks is developing ZW25 based on its Azymetric proprietary platform as the first-line treatment for patients with HER2-overexpressing gastroesophageal adenocarcinoma to be used in combination with standard of care chemotherapy.

Gastroesophageal adenocarcinoma is a rare type of cancer that affects the esophagus, the muscular tube that connects the mouth with the stomach.

Zymeworks' Azymetric platform allows a monospecific antibody, which binds to a single target, to be transformed into a bispecific antibody, binding to two targets simultaneously, reducing drug development costs and timelines.

The company is evaluating ZW25 in phase 1 and phase 2 clinical trials across North America and South Korea.

The FDA has also granted an orphan drug designation to ZW25 for the treatment of both gastric and ovarian cancers.