Chronic lymphatic leukemia, Aifa ok to therapy for remission in 1 year

Green light from the Italian drug agency Aifa for the reimbursement of venetoclax (Venclyxto *) in association with the anti-Cd20 monoclonal antibody obinutuzumab as a therapeutic strategy for all patients diagnosed with chronic lymphocytic leukemia (CLL) for the first time, not previously treated and not suitable for first-line immunochemotherapy type Fcr (fludarabine-cyclophosphamide-rituximab). AbbVie announces this, recalling that every year in Italy over 3 thousand people receive a diagnosis of LLC, the most common type of haematological cancer, which affects men twice as many as women, especially in the age group between 65 and 74 years. “Today, the reimbursement approval of the venetoclax-obinutuzumab combination expands the number of patients who can benefit from the efficacy of the innovative mechanism of action of venetoclax”, a selective inhibitor of the Bcl-2 protein, which reactivates the mechanism of apoptosis (suicide programmed) of cancer cells, “and a fixed duration treatment which, compared to other available continuous therapies, can result in a reduced incidence of adverse events related to the treatment, in an improvement in the quality of life and in a better use of resources With less than one year of therapy, patients diagnosed with treatment-naïve LLC achieve disease remission and prolonged progression-free survival, “said Annalisa Iezzi, Medical Director of AbbVie Italy. With this new indication – underlines the company in a note – the evolutionary history of venetoclax in Llc is completed, which has led the drug to obtain reimbursement in 3 therapeutic indications in just 5 years. Evolution that began in 2017 with the first indication reimbursed in monotherapy, continued in 2019 with the Murano study for relapsed / refractory patients – already establishing itself here as the first chemo-free target therapy with a fixed duration of therapy of 2 years – and now, with this new indication reimbursed for first-line patients, with an even shorter and more sustainable term therapy for the National Health Service. A unique opportunity for LLC patients, AbbVie remarks. “The new indication is an important step forward for both patients and doctors – underlines Alessandra Tedeschi, medical director of the complex of Hematology asst Grande Ospedale Metropolitano Niguarda in Milan – From the pivotal phase III study, CLL145, conducted on 432 patients with previously untreated chronic lymphocytic leukemia, the particular efficacy and tolerability profile of the combination venetoclax plus obinutuzumab emerges in all subgroups of patients, even in those with more unfavorable genetic characteristics. This therapeutic strategy reduces the risk of disease progression or death of the 65% compared to the control arm with standard chemoimmunotherapy with a median follow-up of 65 months. More than 75% of treated patients achieved profound responses, resulting in an undetectable search for minimal residual disease “. “This made it possible to extend the time to the next treatment – the specialist remarks – In fact, after 3 years of follow-up from the suspension of venetoclax, 81% of patients are free from therapy. The possibility of having a therapy, first This line of treatment, with an overall fixed duration of one year, offers the patient suffering from a chronic disease the opportunity to live free from therapy and from all possible adverse events correlated with a benefit in terms of quality of life “.