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FDA starts priority review of Kite’s CAR-T for mantle cell lymphoma

KTE-X19 is also under regulatory review with the EMA

Kite

The US Food and Drug Administration (FDA) has begun a speedy review of Gilead subsidiary Kite's CAR-T therapy KTE-X19 in relapsed or refractory mantle cell lymphoma.

KTE-X19 is already under review with the European Medicines Agency (EMA) for the same indication, and if approved it will become the first CAR-T therapy for this type of cancer.

Both applications are supported by data from the ZUMA-2 trial, which demonstrated that 93% of patients responded to a single infusion of KTE-X19, including 67% of patients achieving a compete response.

However, one caveat to the positive results is the safety profile of KTE-X19. One notable side effect of CAR-T therapies is cytokine release syndrome (CRS) – as CAR T cells multiply, they cause huge amounts of chemicals called cytokines to be released into the bloodstream.

This condition can lead to a host of negative symptoms, and while most cases are fairly mild, it can prove fatal. According to Kite, grade 3 or higher CRS and neurologic events were seen in 15% and 31% of patients, respectively.

“Despite recent advances, patients with relapsed/refractory mantle cell lymphoma currently face a significant lack of effective treatment options once their disease no longer responds to currently available therapy,” said Ken Takeshita, Kite’s global head of clinical development.

“Based on the encouraging results for KTE-X19, we are eager to continue discussions with the FDA on how to bring this innovative treatment to these patients who may benefit from CAR T therapy,” he added.

MCL is an aggressive type of non-Hodgkin’s lymphoma, and although it responds well to initial treatment, it eventually stops responding and the cancer cells continue to multiply.

If approved, KTE-X19 could be a particularly important treatment option for a group of patients who otherwise would be limited.

Other treatment options for advanced MCL include BeiGene’s recently approved BTK inhibitor Brukinsa (zanubrutinib) and AbbVie/Johnson & Johnson’s established BTK inhibitor Imbruvica (ibrutinib).

Gilead/Kite’s approved CAR-T therapy Yescarta (axicabtagene ciloleucel) is available for the treatment of diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma.

The uptake of CAR-T therapies, however, has proven difficult, as the process by which patients’ own T cells are extracted and genetically modified for CAR-T treatment poses a significant issue for the manufacturing of these drugs.

The target action date for the FDA review is due on 10 August 2020, with a final decision due by the end of that month.

Article by
Lucy Parsons

11th February 2020

From: Regulatory

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