Zymeworks receives U.S. FDA Fast Track Designation for ZW191, an FRα-targeting ADC

CAR-T Digest - August 2020

30 March 2026: Zymeworks receives U.S. FDA Fast Track Designation for ZW191, an FRα-targeting ADC

Zymeworks’ FRα-targeting ADC, ZW191, has received FDA Fast Track designation for patients with advanced or metastatic platinum-resistant ovarian cancer, supporting expedited development in this setting
Importantly, the Fast Track status was granted irrespective of FRα expression levels, suggesting the potential to broaden patient eligibility beyond biomarker-selected populations
The designation is expected to accelerate clinical development and regulatory interactions, supporting a more efficient path toward advancing ZW191 in this difficult-to-treat patient population
ZW191 is engineered to target folate receptor-α, which is widely expressed across multiple tumor types, and delivers a novel topoisomerase-1 inhibitor payload designed to enhance tumor cell killing, including potential bystander activity
ZW191 is currently being evaluated in an ongoing Phase 1 clinical trial in patients with advanced solid tumors to assess safety, pharmacokinetics, and preliminary anti-tumor activity