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Zymeworks Receives U.S. FDA Fast Track Designation for ZW191, an FRα-Targeting Antibody-Drug Conjugate
U.S. FDA Fast Track designation granted to ZW191, an antibody-drug conjugate targeting folate receptor-α (FRα), for the treatment of patients with advanced or
About this update from Zymeworks Inc.
[{"type":"text","content":"U.S. FDA Fast Track designation granted to ZW191, an antibody-drug conjugate targeting folate receptor-α (FRα), for the treatment of patients with advanced or metastatic platinum-resistant ovarian cancer (PROC) Ongoing Phase 1 clinical trial of ZW191 enrolling patients with advanced solid tumors to evaluate safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity VANCOUVER, British Columbia, March 30, 2026 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets, while developing a diverse pipeline of novel, multifunctional biotherapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZW191, an antibody-drug conjugate (ADC) targeting folate receptor-α (FRα), for the treatment of patients with advanced or metastatic platinum-resistant ovarian cancer (PROC). ZW191 is an ADC engineered to target FRα, a protein expressed in several tumor types, including approximately 75% of high-grade serous ovarian carcinomas1, over 50% of endometrial cancers,2,3 and ~70% of lung adenocarcinomas4. ZW191’s differentiated design strongly supports its ability to internalize into FR⍺-expressing cells with the potential to release bystander active topoisomerase-1 inhibitor (ZD06519), a novel proprietary payload developed by Zymeworks to kill tumor cells. The FDA’s Fast Track designation program is designed to expedite the development and review timelines of drugs that demonstrate the potential to treat serious conditions, aiming to deliver therapeutics to patients more quickly in areas of unmet need. “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. Notably, the designation was granted irrespective of FRα expression highlighting ZW191’s potential of extending treatment benefits to a broad group of patients without need for biomarker selection,” said Sabeen Mekan, M.D., Senior Vice President and Chief Medical Officer at Zymeworks. “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.” Zymeworks is currently evaluating ZW191 in a Ph...