TNKase is the first stroke drug to win FDA approval in nearly three decades.
The FDA signed off Monday on the use of Roche’s thrombolytic drug TNKase to treat acute ischemic stroke in adult patients.
According to Roche subsidiary Genentech, which announced the label expansion on Monday, TNKase is the first new drug for stroke in almost 30 years. Roche and Genentech also own Activase, the only other acute ischemic stroke (AIS) drug approved by the FDA.
Delivered intravenously, TNKase is a tissue plasminogen activator that works by kicking off a cascade that culminates in dissolving blood clots. In AIS, this mechanism helps prevent the formation of blockages that can constrict the flow of blood to various regions of the brain. TNKase was first approved in 2000 to lower the risk of death in patients with acute heart attack.
Monday’s label expansion was backed by data from a large multicenter trial that established the non-inferiority of TNKase to Activase. Data published in July 2022 in The Lancet showed that 36.9% of patients treated with TNKase 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 Activase arm reached the same outcome. The risk difference estimate was 2.1%, which satisfied the threshold of non-inferiority.
In a statement on Monday, Genentech Chief Medical Officer Levi Garraway called TNKase’s label expansion a “significant step forward” for the company and for patients, for whom the drug can provide “a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke.”
Monday’s label expansion also continues Roche’s regulatory run in recent months.
Last month, for instance, the company’s SMN2 splicing modifier Evrysdi became the first FDA-approved tablet for spinal muscular atrophy, a rare motor disorder. The pill “combines established efficacy with convenience,” Garraway said at the time, and is expected to make the drug easier to take for patients.
Months earlier, in September 2024, Roche—alongside partner Sanofi—won the FDA’s approval for the industry’s first biologic treatment for chronic obstructive pulmonary disease. Dupixent, a blockbuster anti-IL4-alpha antagonist, was cleared for the lung condition after Phase III trials demonstrated a 30% to 34% drop in the rate of exacerbations versus placebo.
In April 2024, Roche’s Genentech also snagged approval for Alecensa as the first and only ALK inhibitor for the adjuvant treatment of ALK-positive non-small cell lung cancer patients with early-stage disease who had undergone surgical resection.
