FDA Approves Genentech’s TNKase for Acute Ischemic Stroke

Genentech, a Roche Group member, has secured FDA approval for TNKase® (tenecteplase) as a treatment for acute ischemic stroke (AIS) in adults. This milestone makes Genentech the only company with two FDA-approved AIS treatments, TNKase and Activase® (alteplase). Unlike Activase, which requires a 60-minute infusion, TNKase is administered as a five-second IV bolus, streamlining stroke care. To support this new approval, Genentech plans to launch a 25 mg vial configuration in the coming months.

Stroke remains the fifth leading cause of death in the U.S., affecting over 795,000 people annually. The FDA’s decision was based on the AcT trial, a large, multi-center study demonstrating TNKase’s safety and efficacy compared to Activase. Conducted by the University of Calgary and funded by the Canadian Institute of Health Research, the study enrolled patients from 22 stroke centers across Canada. TNKase is also approved for treating acute ST-elevation myocardial infarction (STEMI), further solidifying its role in cardiovascular and stroke care.