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FDA Approves Novartis’ CAR-T Therapy, Kymriah, for the Treatment of Follicular Lymphoma

Anna Osborne
30 May 2022
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Leading global medicines company, Novartis, has announced the FDA has granted accelerated approval for its CAR-T cell therapy, Kymriah, targeting adult patients with relapsed or refractory follicular lymphoma, after two, or more, lines of systemic therapy.

This is the third indication the FDA has approved Novartis’ Kymriah for, and it remains the only CAR-T cell therapy approved for both pediatric and adult treatments. It also follows the European Commission’s approval of Kymriah for this indication in early May 2022.

The approval is based on data from Novartis’ open-label Phase II ELARA clinical trial, in which 90 patients with relapsed or refractory follicular lymphoma received Kymriah treatment.

Patients were evaluated at a median follow-up of 17 months, with 86% achieving a response. This included 68% who experienced a complete response. An estimated 85% of those achieving complete responses still showed the same response 12 months later, demonstrating prolonged durable results.

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Kymriah was also demonstrated to be effective in high-risk categorized patients including those who had received heavy prior treatment, were refractory, suffered from bulky disease or POD24, and those with high follicular lymphoma international prognostic index (FLIPI) scores.

“Patients with follicular lymphoma who relapse or don’t respond to treatment have a poor prognosis and may face a series of treatment options without a meaningful, lasting response. This new, effective option for patients with follicular lymphoma may offer long-term benefit,” comments Stephen J. Schuster, Principal Investigator on the trial.

In terms of safety profile, ELARA demonstrated that 53% of the 97 trial participants evaluated at a median 21-month follow-up reported experiencing any-grade of cytokine release syndrome (CRS). However, there were no reported cases of CRS in grade 3 or above. 43% of patients experienced any-grade neurological side-effects, with 6% of the patients reporting a high-grade neurological event.

Patients with follicular lymphoma are typically treated with multiple lines of cancer therapy, from a median of 4 to the upper range of 13 lines. The efficacy of these treatments decreases substantially in the later lines experienced by these relapsed or refractory patients.

“We hope this treatment option, that has the potential for long-lasting results, may help break the unrelenting cycle of treatment for patients with follicular lymphoma. We are on a mission to build on our pioneering work in cell therapy and continue to innovate for patient impact,” said Victor Bulto, President of Novartis Innovative Medicines US.

In accordance with the Accelerated Approval Program, Kymriah for relapsed or refractory follicular lymphoma will be subject to confirmatory trials to prove its clinical benefit, as well as the verification of results, to maintain continued approval status.

Kymriah was the first CAR-T to gain regulatory approval – as a treatment for acute lymphoblastic leukaemia in patients under 25. This month the first ever pediatric patient to receive Kymriah, Emily Whitehead,  is celebrating 10 years in remission. To mark this, here at Phacilitate we featured a whole host of CAR-T content, take a look here >> 

Source: Novartis Press Release


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