On May 4, 2022, Kymriah EMA Approval for the Treatment of Follicular Lymphoma (FL)

On May 4, 2022, Kymriah EMA Approval for the Treatment of Follicular Lymphoma (FL)

On May 4, 2022 (Basel), Novartis announced that the European Commission has expanded the approval of Kymriah (tisagenlecleucel) to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Novartis stated that this product is the first CAR-T cell therapy approved in Europe for this indication.

The approval was based on the global Phase II ELARA trial, which showed that 86% of patients treated with Kymriah responded, with 69% achieving a complete response (CR). An estimated 87% of patients who achieved a CR were estimated to maintain their response for 9 months or longer after their initial response, demonstrating durable long-term responses to the treatment. In the trial, efficacy was evaluated in 94 infused patients, with a median follow-up of approximately 21 months.

In the 97 patients evaluable for safety, Kymriah demonstrated a notable safety profile. 50% of patients reported cytokine release syndrome (CRS) after Kymriah infusion, with no Grade 3 or 4 events per the Lee grading scale reported. Within 8 weeks of Kymriah infusion, 9% of patients (1% Grade 3 or 4) experienced neurological adverse events. 16% of patients experienced serious infections (Grade 3 or 4).

Apart from r/r FL, Kymriah is also approved for the treatment of pediatric and young adult patients up to 25 years of age with refractory B-cell acute lymphoblastic leukemia (ALL), post-transplant relapsed or second or later relapse, and adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Kymriah (Tisagenlecleucel) was initially approved in Europe in 2018 for the treatment of pediatric and young adult patients up to 25 years of age with refractory B-cell acute lymphoblastic leukemia, post-transplant relapsed or second or later relapse. The CAR-T cell therapy was simultaneously cleared for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.

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