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Yescarta gains first FDA approval for indolent follicular lymphoma

First CAR-T cell therapy to be approved in this indication

Gilead subsidiary Kite's Yescarta has been granted accelerated approval from the US Food and Drug Administration (FDA) for indolent follicular lymphoma, becoming the first CAR-T cell therapy approved in this indication.

Specifically, Yescarta (axicabtagene ciloleucel) has been approved for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) – a form of indolent non-Hodgkin lymphoma (iNHL) – after two or more lines of therapy.

The accelerated approval is based on the phase 2 ZUMA-5 trial, an open-label study evaluating 146 patients with relapsed or refractory iNHL, in which 125 FL patients and 16 marginal zone lymphoma patients were enrolled and treated with Yescarta following two or more prior lines of therapy.

Overall, 91% of patients with relapsed or refractory FL patients responded to Yescarta, with an estimated 74% of patients in a continued remission at 18 months.

This included 60% of patients who achieved a complete remission, and 13 of the 25 patients who achieved a partial remission also met imaging criteria for a complete remission, but hadn’t been confirmed by a negative bone marrow biopsy after treatment.

However, the FDA has approved Yescarta with a boxed warning for risks of cytokine release syndrome (CRS) and neurologic toxicities, with the CAR-T therapy authorised with a risk evaluation and mitigation strategy (REMS).

A REMS is used by the FDA when a medication carries ‘serious safety concerns’ to help ensure that the benefits of the treatment outweigh the risks.

In the ZUMA-5 trial, 21% of patients experienced grade 3 or worse neurologic side effects and 8% experienced CRS.

Yescarta is already approved to treat adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.

Also approved for the treatment of large B-cell lymphoma is Novartis’ rival CAR-T therapy Kymriah (tisagenlecleucel) and Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel), which are both approved in the third-line treatment setting.

As the first CAR-T therapy approved in the indolent FL setting, Yescarta will have space to grow without encroaching competition from its rivals.

Kite also recently revealed some positive data for Yescarta in the first-line setting for patients with high-risk large B-cell lymphoma.

In the ZUMA-12 trial, after a single infusion of Yescarta (axicabtagene ciloleucel), 85% of LBCL patients achieved a response, while 74% of patients achieved a complete response.

After a median follow-up of 9.5 months, the median progression-free survival, median overall survival and median duration of response were not yet reached.

An approval in the first-line setting would give Yescarta another boost against its rivals, especially as Novartis' Kymriah is also being studied in relapsed or refractory FL – meaning Kite’s CAR T may not hold market exclusivity in this indication for long.

Article by
Lucy Parsons

9th March 2021

From: Regulatory



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