A committee of the European Medicines Agency (EMA) has recommended the conditional approval of Tecartus (brexucabtagene autoleucel) for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL).
The recommendation by the Committee for Medicinal Products for Human Use (CHMP) for Kite Pharma‘s CAR T-cell therapy is specific for patients who received at least two prior lines of therapy, including a Bruton’s tyrosine kinase inhibitor (BTKi).
A conditional marketing authorization is given to medicines that fulfil a medical need and whose benefit of immediate availability outweighs the risk of having less comprehensive data. This authorization is valid for one year, but can be renewed annually. Additional data is required before full approval is granted.
The European Commission will review the committee’s opinion before making a decision in the coming months.
“This opinion is an important milestone for patients in Europe living with relapsed or refractory mantle cell lymphoma,” Ken Takeshita, MD, Kite’s global head of clinical development, said in a press release.
“Kite is committed to bringing the promise of CAR T cell therapy to patients with [blood] cancers and, pending approval by European Commission, we hope to bring this innovative treatment option forward for patients in Europe as quickly as possible,” he added.
Tecartus, developed by Gilead Sciences-owned Kite and formerly known as KTE-X19, is a type of immunotherapy in which a person’s own T-cells — a type of immune cell involved in the fight against cancer — are collected and genetically modified in the lab to better fight cancer, after which they are expanded and infused back into the patient.
Specifically, Tecartus contains T-cells engineered to produce a man-made chimeric antigen receptor, or CAR, that helps them recognize and kill cells containing CD19 — a protein found at high levels on certain malignant B-cells — while leaving healthy cells unharmed.
This therapy shares the same design as the company’s first approved CAR T-cell therapy, Yescarta (axicabtagene ciloleucel), but it has an additional manufacturing step in which circulating tumor cells are separated from immune cells — a necessary step for some B-cell cancers like MCL.
The CHMP’s recommendation and the FDA’s approval were based on data from the ZUMA-2 Phase 2 trial (NCT02601313), which enrolled 105 MCL patients who had received up to five prior therapies, including a chemotherapy, an anti-CD20 antibody, and a BTKi.
Results from this open-label study showed that 87% of patients responded to a single dose of Tecartus, with 62% achieving a complete cancer eradication.
Also, one year after treatment, 83% of the first 28 participants were still alive, and 61% of them had no signs of disease progression.
Tecartus showed a generally manageable safety profile. Severe or life-threatening adverse events included neurologic toxicity (37%) and cytokine release syndrome (18%), a serious inflammatory response triggered by the therapy. A warning about these side effects has been included on the therapy’s U.S. prescribing information.
Tecartus is also under investigation for adults with chronic lymphocytic leukemia and small lymphocytic lymphoma patients in the ZUMA-8 Phase 1 trial (NCT03624036), and for children and adolescents with acute lymphoblastic leukemia and B-cell non-Hodgkin’s lymphoma in the ZUMA-4 Phase 1/2 trial (NCT02625480).
Both trials are currently recruiting participants; for more information on contacts and locations, click on their identifiers.
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