The European Medicines Agency (EMA) today recommended granting conditional marketing authorization to brexucabtagene autoleucel (Tecartus), making it the first approved chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) in the European Union.
Brexucabtagene autoleucel is the third CAR T-cell therapy to be recommended for approval in Europe, but the only one for this indication.
The agent was approved for the same use in the United States earlier this year and was described by one expert as representing a “new frontier” in the treatment of MCL.
The new agent addresses an unmet need in MCL for patients who relapse or progress despite available therapies.
The current standard of care for this cancer includes stem cell transplantation and various therapy regimens, including Bruton’s tyrosine kinase (BTK) inhibitors, all of which are often initially effective. However, patients commonly relapse or stop responding to treatment, according to the EMA.
“This opinion is an important milestone for patients in Europe living with relapsed or refractory mantle cell lymphoma,” said Ken Takeshita, MD, global head of clinical development at Kite, the agent’s manufacturer, in a press statement.
It is based on safety and efficacy results from the multicenter, single-arm ZUMA-2 trial in 74 adult patients with refractory or relapsed MCL who had received at least two prior therapies.
During the study’s 12-month follow-up period, 84% of patients had a partial response and 59% had a complete response.
The most common side effects are cytokine release syndrome, infections, and encephalopathy. Monitoring and mitigation strategies for these side effects are described in the product information and the agent’s risk management plan.
Further efficacy and safety data are being collected as part of long-term follow-up from the pivotal study and an additional registry-based study.
Brexucabtagene autoleucel was supported through EMA’s Priority Medicines (PRIME) initiative, which provides early and enhanced scientific and regulatory support to medicines that have the potential to address unmet needs.
Nick Mulcahy is an award-winning senior journalist for Medscape. He previously freelanced for HealthDay and MedPageToday, and had bylines in WashingtonPost.com, MSNBC, and Yahoo. Reach him by email and follow him on Twitter.