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Tenecteplase Receives FDA Approval, Marking First New Stroke Medication in Nearly 30 Years
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In a clinical trial, tenecteplase was shown to be a comparable alternative to alteplase.
Updated on March 3, 2025, at 2:28PM.
The FDA has approved tenecteplase (TNKase; Genentech), a thrombolytic or clot-dissolving agent, for the treatment of adult patients with acute ischemic stroke (AIS). With this action, tenecteplase has become the first stroke medicine to be approved by the FDA in nearly 30 years.1
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Tenecteplase is delivered via a single, 5-second intravenous (IV) bolus, which is a fast and simpler administration method compared with standard of care alteplase (Activase; Genentech), which is administrated as an IV bolus followed by a 60-minute infusion. The recommended dosage and administration say to initiate treatment as soon as possible and within 3 hours after the onset of stroke symptoms. Additionally, this approval will allow the introduction of a new 25-mg vial configuration within the upcoming months to further support the use of tenecteplase for AIS.1
Affecting more than 795,000 people each year, strokes are the fifth leading cause of death and the leading cause of long-term disability in the US. During an AIS, brain damage occurs and progresses rapidly, meaning every moment without intervention can lead to irreversible loss of nervous tissue. Because of these detrimental effects, immediate medical care is crucial for patients.1
The approval of tenecteplase is based on results from the prospective, randomized, controlled, open-label, parallel group phase 3 clinical trial, AcT (NCT03889249)2, which were published in The Lancet.3 The trial aimed to determine whether single-bolus tenecteplase might increase reperfusion when compared with alteplase, the first treatment from Genentech to be FDA-approved for the treatment of AIS. Patients were enrolled from 22 Canadian primary and comprehensive stroke centers and randomly assigned to receive either tenecteplase (n = 816; 0.25 mg/kg to a maximum of 25 mg) or alteplase (n = 784; 0.9 mg/kg to a maximum of 90 mg; 0.09 mg/kg as a bolus, and then a 60-minute infusion of the remaining 0.81 mg/kg). Patients were eligible for inclusion if they had a diagnosis of AIS causing disabling neurological deficit, presented within 4.5 hours of symptom onset, and were eligible for thrombolysis per Canadian guidelines.2,3
The trial’s primary end point was the proportion of patients who had a modified Rankin Scale (mRS) score of 0 to 1 at 90 to 120 days after treatment, assessed via blinded review in the intention-to-treat population. Safety was assessed in all patients who received any of either thrombolytic agent and who were reported as treated.2,3
A total of 1600 patients aged 18 years and older (median age: 74 years; IQR 63–83) were enrolled between December 10, 2019, and January 25, 2022. Most of the patients were male (52.1%; n = 822) and the remaining were female (47.9%; n = 755). As of data cutoff on January 21, 2022, 296 (36.9%) of 802 patients in the tenecteplase group and 266 (34.8%) of 765 in the alteplase group had an mRS score of 0 to 1 at 90 to 120 days (unadjusted risk difference: 2.1%; 95% CI [2.6–6.9]). This met the prespecified non-inferiority threshold, according to the authors.3
Further, in safety analyses, only 27 (3.4%) patients in the tenecteplase group and 24 (3.2%) in the alteplase group had 24-hour symptomatic intracerebral hemorrhage. Approximately 122 (15.3%) and 117 (15.4%) of patients in their respective groups died within 90 days of treatment initiation.3
“Today’s approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in a news release. “[Tenecteplase] provides a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke.”1
