FDA Approves First New Stroke Drug, Tenecteplase, in Nearly 30 Years
The US Food and Drug Administration (FDA) has approved tenecteplase (TNKase®), a thrombolytic agent developed by Genentech, for the treatment of acute ischemic stroke (AIS) in adults.
Tenecteplase, a “tissue plasminogen activator, clot-dissolving, thrombolytic medicine,” is administered as a single five-second intravenous (IV) bolus, offering a faster and more simplified administration compared to standard-of-care alteplase, which requires an IV bolus followed by a 60-minute infusion.
This approval makes TNKase the second FDA-approved thrombolytic for AIS, reinforcing Genentech’s role in advancing stroke treatment. It is also FDA-approved for the treatment of acute ST-elevation myocardial infarction (STEMI) in adult.
The approval is supported by findings from the AcT (alteplase compared to tenecteplase) trial, a multi-center, non-inferiority study led by the University of Calgary and funded by the Canadian Institute of Health Research. Conducted across 22 stroke centers in Canada, the study demonstrated that tenecteplase was comparable to alteplase in both safety and efficacy in AIS patients with a disabling neurological deficit.
Trial data published in The Lancet in July 2022 showed that 36.9% of patients treated with tenecteplase had no to nonsignificant disability as measured by the modified Rankin Scale, a validated tool that doctors use to assess global disability in stroke patients. In comparison, 34.8% of comparators in the alteplase arm reached the same outcome. The risk difference estimate was 2.1%, which satisfied the threshold of non-inferiority.
The simpler administration and similar clinical outcomes position TNKase as a valuable alternative for stroke intervention, where timely treatment is critical. The medication’s label states to initiate treatment as soon as possible and within 3 hours after the onset of stroke symptoms.
Clinicians should note the contraindications of TNKase, including active internal bleeding, recent brain or spinal surgery, severe uncontrolled hypertension, brain tumors, and specific cerebrovascular abnormalities. For AIS, active brain bleeding is an additional contraindication. The most common adverse reactions are bleeding and hypersensitivity reactions.
A black box warning emphasizes the risk of serious bleeding, including intracranial hemorrhage, and potential complications such as thromboembolism, cholesterol embolization, and arrhythmias. Patients receiving tenecteplase should be monitored for signs of bleeding and neurological changes.
References
