Kite, a Californian company owned by Gilead but operating independently, announced the approval of Tecartus (brexucabtagene autoleucel) by the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
The approval marks the first time a company has had two approved CAR-T therapies in its portfolio, and the first CAR-T treatment for MCL.
The FDA reached its decision after clinical data showed that 87% of patient responded to a single infusion of Tecartus, with 62% achieving a complete response.
In terms of manufacturing, the product will be produced out of Kite’s El Segundo, US, facility. The company outlined a 96% manufacturing success rate, as well as a median turnaround time of 15 days to produce the therapy and then treat the patient.
Both of these are noteworthy, given the complicated manufacturing process for CAR-T therapies can lead to delays. Not long after Novartis’ CAR-T product’s approval, the company had admitted struggles producing its treatment on-spec.
The next step for Kite’s therapy will be its assessment by the European Commission for approval within the region; the treatment has already been designated a priority medicines designation to speed up the review process.
Following the marketing authorization of Kite’s manufacturing base in Amsterdam, the Netherlands, the company will have the option to produce Tecartus from this location, should it receive regulatory approval.
Kite is also exploring the potential for Tecartus to be used to treat acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia. The company has taken the treatment to Phase I/II trials in both indications.