Tenecteplase No Longer Off-Label as Stroke Lytic

The FDA approved tenecteplase (TNKase) for adult stroke patients, Genentech announced on Monday.

A clot-dissolving tissue plasminogen activator (tPA), tenecteplase is now indicated for acute ischemic stroke on top of its older approval in acute ST-elevation myocardial infarction. Tenecteplase thus officially joins the other stroke thrombolytic approved stateside, alteplase (Activase), which is also marketed by Genentech.

Notably, off-label tenecteplase had already become the preferred thrombolytic for acute ischemic stroke before the expanded indication.

“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, Genentech’s chief medical officer, in a statement. “Today’s approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients.”

FDA approval was based on the AcT noninferiority trial that found tenecteplase (at 0.25 mg/kg) to be at least on par with alteplase for safety and efficacy in acute ischemic stroke in Canadians presenting within 4.5 hours of symptom onset.

Tenecteplase’s updated label calls for IV administration as a single bolus over 5 seconds. Treatment should be initiated as soon as possible and within 3 hours of stroke onset.

For later-presenting stroke patients, however, this excludes the possibility of an extended window for IV thrombolysis in select stroke patients for whom thrombectomy is not available or indicated. Earlier, the TRACE-III trial had found that late administration of tenecteplase was of clinical benefit in the 4.5- to 24-hour window after a stroke in situations where thrombectomy was not available immediately.

Genentech noted that tenecteplase is the first stroke medicine approved by the FDA in nearly 30 years.

The label for the drug warns of bleeding, hypersensitivity, and arrhythmias with its use. There have also been reports of cholesterol embolization among lytic recipients and thromboembolism in those with a left heart thrombus.

Tenecteplase is contraindicated for stroke patients with active internal bleeding, active intracranial hemorrhage, and severe uncontrolled hypertension, among other criteria.

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