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FDA grants orphan drug designation to ZW25 and ZW33 for ovarian cancer treatment
The FDA granted orphan drug designation to ZW25 and ZW33 for the treatment of ovarian cancer, according to the agents’ manufacturer.
“We’re pleased that the FDA has recognized the significant need for new and better therapies for women with ovarian cancer, which remains the leading cause of death due to gynecological malignancies,” Diana Hausman, MD, chief medical officer of Zymeworks, said in a company-issued press release. “The granted orphan drug designations underscore the potential of both ZW25 and ZW33 in addressing this important unmet medical need. We are looking forward to initiating clinical development for this indication in the very near future.”
ZW25 is a novel bispecific antibody designed to target two different epitopes of the HER-2 protein, overexpressed on the surface of several tumor types, including ovarian, lung, breast and gastric cancers. Phase 1 clinical development is due to begin in late August.
ZW33 is a drug-conjugated version of ZW25. An investigational new drug filing is expected early next year.
“We are very excited with the potential of our novel engineered bispecific antibody ZW25 and its drug conjugate, ZW33, as new treatment options for patients with ovarian cancer,” Gordon Ng, PhD, chief scientific officer of Zymeworks, said in the press release. “We believe ZW25’s and ZW33’s multiple differentiated mechanisms of action can be significantly more efficacious than current HER-2–directed treatments for HER-2–expressing cancers and can enhance the range of current treatments available to these patients.”