FDA Approves Tenecteplase Treatment for Acute Ischemic Stroke
TNKase (Tenecteplase; Genentech, South San Francisco, CA) has received approval from the Food and Drug Administration (FDA) for the treatment of adults with acute ischemic stroke. TNKase is a tissue plasminogen activator, thrombolytic agent that is administered as a single 5-second intravenous (IV) bolus. According to a statement from Genentech, the company expects to introduce a new 25 mg vial configuration for TNKase in the first half of 2025.
The approval was based on data from the phase 3 AcT clinical trial (NCT03889249), which evaluated whether TNKase is noninferior to Activase (alteplase; Genentech, South San Francisco, CA) in terms of safety and efficacy. AcT included an intention-to-treat population of 1577 adult participants from 22 stroke centers in Canada who were randomized 1:1 to receive either TNKase (n=806) or Activase (n=771). The primary endpoint was freedom from disability between days 90 to 120 after treatment as defined by a score of 0 or 1 on the Modified Rankin Scale (mRS).
The proportion of participants who reached the primary endpoint in both studies was comparable:
- 36.9% (n=296) of participants who received TNKase
- 34.8% (n=266) of participants who received Activase
- Unadjusted risk difference: 2.1% (95% CI, 2.6 to 6.9)
Furthermore, in the safety analysis, TNKase and Activase demonstrated comparable rates of 24-hour symptomatic intracerebral hemorrhage (TNKase, 34%; Activase, 3.2%) and death (TNKase, 15.3%; Activase, 15.4%) at 90 days.
“TNKase provides a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke,” said Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development of Genentech.
TNKase was previously approved for the treatment of adults with acute ST-elevation myocardial infarction (STEMI).