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Europe approves the first "blood cancer" therapy based on the "Car-t" technique, which involves the use of "trained" patient cells to recognize tumors. The green light for Kymriah comes from the Chmp, the Ema committee that deals with drug approvals.
The positive opinion about Kymriah concerns acute refractory lymphoblastic leukemia (Lla) B and post-transplantation. or secondary or subsequent recurrence, in patients younger than 25 years of age, and diffuse diffuse large B-cell (Dlbcl) diffuse or refractory lymphoma after two or more lines of systemic treatment in adults.
On the other hand, Yescarta concerns adult patients with diffuse or refractory large B-cell diffuse lymphoma (Dlbcl) or primary mediastinal B lymphoma (Pmbcl), after two or three lines of systemic treatment. The European Commission will now have to evaluate the positive opinion expressed and then issue the final Ema decision. Further negotiations on prices and reimbursements will take place at the level of individual Member States
"This therapy offers a hope of cure to a group of patients for whom there was no cure before – explains Franca Fagioli , president of the Italian Hematology and Pediatric Oncology Association As for leukemia, it could work for the 20% of patients for whom the available drugs have no effect, although it should be remembered that It should only be administered in highly specialized centers. "
" Car-T cells transform the fight against serious and often fatal diseases in the EU, "comments Martina Schüssler-Lenz, President of the Innovative Therapies Committee These are "innovative treatments that have the potential to change the perspectives of cancer patients," notes Tomas Salmonson, Chair dicinals for human use "but they also bring new scientific and regulatory challenges". On one side, the "cost node", on the other the security chapter. With regard to these, for Ema "an important measure of risk management is the use of a patient registry to monitor the long-term effectiveness and safety" of these innovative therapies "As a condition for" The positive opinion of the Chmp for tisagenlecleucel represents an important turning point for pediatric and adult European patients with aggressive hematologic tumors – says Liz Barrett, CEO of Novartis Oncology – This truly transformative therapy helps to satisfy a deep unmet need, and Novartis is proud that its leadership in the innovation of Car-T therapies can make a significant difference for European patients. "If approved by the European Commission, the company states that" tisagenlecleucel will become the first Car-T cell therapy available in the EU for both Dlbcl and for Lla protein. "
Europe, a Novartis release recalls: who developed the therapy, Lla accounts for about 80% of leukemia cases, while Dlbcl is the most prevalent subtype of non-Hodgkin's lymphoma. "In Italy, it is estimated that each year, 70 to 80 patients with ALL and about 700 for the other pathology could benefit from the therapy – explains Paolo Corradini, president of the Italian Society of Hematology -. But Car-t is the first antineoplastic cell therapy in the history of humanity, this approval is the first of a long series, as there are promising experiments for many other indications. "
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