Home » Lymphomas and multiple myeloma: Aifa has approved reimbursement for two Car-T therapies

Lymphomas and multiple myeloma: Aifa has approved reimbursement for two Car-T therapies

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Lymphomas and multiple myeloma: Aifa has approved reimbursement for two Car-T therapies

The landscape of CAR-T therapies, the form of immunotherapy that aims to fight tumors by arming the cells of the immune system in the laboratory, is constantly changing. Both on the research and diffusion front in clinical practice, and on the regulatory front. In this context, recent news is that the Italian Medicines Agency has approved the reimbursement of two Car-T-based therapies directed against some forms of lymphomas and, for the first time, against multiple myeloma in relapsed or refractory cases after different therapies. Specifically, these are lisocabtagene maraleucel and idacabtagene vicleucel, both classified as class H medicines (i.e. hospital-based and reimbursed by the national health system).

CAR-T therapies, 31 authorized centers in Italy by Tiziana Moriconi 13 November 2023

How Car-Ts work

These are gene therapy products, in which T cells – part of the immune system – are taken from patients and modified to make them more able to recognize and attack tumor cells that present a certain target. In the case of lisocabtagene maraleucel the target is the CD19 protein (a target present on B lymphocytes, and also a target of other Car-T therapies), while for idecabtagene vicleucel (ide-cel) it is the BCMA protein, present on plasma cells. In both cases, once the patients’ T cells have been modified they are reintroduced into the patients, in a single infusion (this is why they are called one-shot therapies). Using cells as a therapy tool, they are considered “living drugs”.

Car-Ts are complex therapies that require highly specialized teams and centers to prepare patients for the collection and subsequent administration of the modified cells. To date, in Italy there are over 30 centers authorized to provide them, present in 15 regions.

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Lymphoma, a new therapy based on modified cells approved in Europe by Dario Rubino 11 April 2022

Therapeutic indications for lisocabtagene maraleucel and idacabtagene vicleucel

Like the other Car-Ts currently on the market, lisocabtagene maraleucel and ide-cel are reserved for the most difficult to treat patients, those in whom the disease progresses or returns after other lines. Specifically, lisocabtagene maraleucel is indicated for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and grade 3B (FL3B) follicular lymphoma, after at least two lines of systemic therapy.

Multiple myeloma, what it is and how to treat the tumor by Giovanni Allevi by Tina Simoniello 07 February 2024

Ide-cel is instead indicated for patients with multiple myeloma in disease progression, after having received at least three previous therapies. In the decisions relating to drugs, it is established that the ex-factory price will be 345 thousand euros for lisocabtagene maraleucel and 350 thousand for ida-cel (with discount for accredited public and private healthcare facilities).

Multiple myeloma, the first CAR-T therapy arrives by Tiziana Moriconi 01 September 2021 Topics

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