NEW YORK – The European Commission on Wednesday approved Novartis' autologous CAR T-cell therapy Kymriah (tisagenlecleucel) for relapsed or refractory follicular lymphoma patients.
The EC's approval, which makes the anti-CD19 cell therapy available for adult patients with grade 1, 2, and 3A follicular lymphoma after two or more lines of systemic therapy, follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in March.
In April, the EC granted marketing authorization to Bristol Myers Squibb's CD19-directed CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) for the treatment of various relapsed or refractory lymphoma indications including for grade 3B follicular lymphoma after two or more lines of systemic therapy.
In approving Kymriah, regulators reviewed the results of the Phase II ELARA clinical trial, in which 86 percent of 94 patients responded to the treatment at a median follow-up of 21 months and 69 percent had a complete response. After nine months, 87 percent of complete responders were still responding to treatment. Of 97 patients in the safety-evaluable portion of the trial, 50 percent experienced cytokine release syndrome, and none of the patients experienced any grade 3 or 4 adverse events.
Last year, Novartis also filed a marketing application with the US Food and Drug Administration for Kymriah's use in treating follicular lymphoma, but that decision is still pending. In the US, as in Europe, the cell therapy is approved for children with refractory B-cell acute lymphoblastic leukemia and adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of therapy.
The European approval makes Kymriah available to this follicular lymphoma patient population across 27 EU member states plus Iceland, Norway, and Liechtenstein.