FDA fast tracks treatment for advanced, resistant ovarian cancer
Phase 1 trial of Zymeworks' ZW191 actively recruiting at several sites
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The U.S. Food and Drug Administration (FDA) has granted fast-track designation to the experimental therapy ZW191 as a potential treatment for hard-to-manage ovarian cancer.
The designation covers ZW191’s potential use in ovarian cancer that is advanced or metastatic — meaning the cancer has begun to spread beyond the ovaries — and that is resistant to standard platinum-based chemotherapies.
The FDA grants fast-track designation to investigational medicines with the potential to address unmet needs in the treatment of serious conditions, with the goal of speeding the development of important new therapies. With this designation, ZW191’s developer, Zymeworks, will have access to perks such as more frequent communication with the FDA during the drug development process.
“Receiving Fast Track Designation for ZW191 highlights the potential of this program to address significant unmet medical needs for patients with previously treated advanced ovarian cancer,” Sabeen Mekan, MD, senior vice president and chief medical officer of Zymeworks, said in a company press release.
Using antibodies to target cancer cells
ZW191 belongs to a class of anticancer medicines called antibody-drug conjugates (ADCs). These therapies essentially work by attaching a toxic molecule to an antibody that targets a protein expressed on cancer cells. The idea is that the antibody will bind to the protein and, in doing so, deliver the toxic molecule directly to the cancer cell, killing it. ZW191, which is given directly into the bloodstream, uses an antibody that targets the folate receptor alpha (FR-alpha).
Mekan said the FDA fast track designation “was granted irrespective of FR[alpha] expression,” which highlights “ZW191’s potential of extending treatment benefits to a broad group of patients without need for biomarker selection.”
“This designation also further reinforces our expertise in ADC development, and we look forward to working closely with the FDA to advance this program for patients with difficult-to-treat cancers,” Mekan said.
Zymeworks is sponsoring a Phase 1 clinical trial (NCT06555744) evaluating the safety and anticancer activity of ZW191 in people with various solid tumors. The company expects results from the study to inform the drug’s future development. The trial is actively recruiting participants at sites in the U.S., Australia, Japan, Singapore, South Korea, and Spain.
