Novartis announced that The European Commission (EC) has approved Tisagenlecleucel, Car-T cell therapy, for the treatment of adult patients with relapsed or refractory (r / r) follicular lymphoma (Lf) after two or more lines of systemic therapy. The approval follows the March positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is applicable to all 27 EU Member States European, plus Iceland, Norway and Liechtenstein. This approval – reads a note – represents the third indication for Tisagenlecleucel and makes it the first Car-T cell therapy approved in the EU for patients with relapsed and refractory grade 1, 2 and 3A follicular lymphoma.
“When follicular lymphoma does not respond to treatment, or recurs, it becomes more aggressive and difficult to treat; patients often end up receiving multiple lines of therapy, with diminishing benefits,” he said. Pier Luigi Zinzani, president of the Sie training activities commission and full professor of Hematology at the University of Bologna. “Approval of Tisagenlecleucel in Europe brings follicular lymphoma patients closer to therapy with curative potential, giving them hope for better outcomes“.
The approval is based on the results of the global phase II study ‘Elara’, in which 86% of patients treated with Tisagenlecleucel had a response, including 69% who had a complete response (Cr). A durable and prolonged response to treatment was also demonstrated: 87% of patients maintained a complete response for 9 months or more after the initial response. In the study, 94 infused patients were evaluated for efficacy, with a median follow-up of approximately 21 months. Among 97 patients evaluable for safety, the tolerability profile of Tisagenlecleucel was good. Cytokine release syndrome (Crs) has been reported in 50% of patients after infusion of Tisagenlecleucel and no grade 3 or 4 Lee scale events have been reported. Neurological adverse reactions occurred in 9% of patients (1% were Grade 3 or 4) within eight weeks of Tisagenlecleucel infusion. Severe infections (grade 3 or 4) occurred in 16% of patients.
“In line with the experience gained in the treatment of other types of lymphoma such as, for example, relapsed or refractory diffuse large B-cell lymphoma, Tisagenlecleucel has proven to be an innovative, effective therapy with a good safety profile even in patients with relapsed or refractory follicular lymphoma“, he declares Andrés JM Ferreri, president of the Italian Lymphoma Foundation (Fil) and director of the Lymphoma Unit of the Irccs San Raffaele hospital in Milan. “This approval represents an important step to significantly improve the chances of recovery of a numerically significant and critical population of oncohematology patients.”
“Thanks to this new approval we are happy to be able to extend the range of action of this advanced therapy to a greater number of patients living with relapsing follicular lymphomaand, ”he said Marie-France Tschudin, president of Innovative Medicines International and Chief Commercial Officer at Novartis. “With durable responses and a safety profile that allows for flexible administration, we are doing what we can to rewrite cancer survival and ease the burden of this disease on patients and the healthcare system.”
Tisagenlecleucel – finally the company note recalls – is also approved for the treatment of pediatric patients and young adults up to 25 years with refractory B-cell acute lymphoblastic leukemia (Lla), in post-transplant relapse or in second or subsequent relapse and adult patients with diffuse large B cell lymphoma (Dlbcl – diffuse large B cell lymphoma) r / r after two or more lines of systemic therapy.
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