Green light for reimbursement by the Italian Medicines Agency (Aifa) for a new therapy for patients with acute myeloid leukemia not suitable for intensive chemotherapy. The therapy, which combines the drug venetoclax with azacitidine, reduces the risk of death by 42%.
Green light for reimbursement by the Italian Medicines Agency (Aifa) for a new therapy for patients with acute myeloid leukemia not suitable for intensive chemotherapy. The therapy, which combines the drug venetoclax with azacitidine, reduces the risk of death by 42%. AIFA has also granted the therapy the denomination of full innovation, which allows innovative drugs to be included in the Fund.
Acute myeloid leukemia is an aggressive blood cancer that affects around 3,300 people in Italy each year, with most cases presenting in old age. Elderly or frail patients suffering from other pathologies do not tolerate intensive chemotherapy. The current therapy for these patients is based on hypomethylating agents, which induce responses in no more than 20% of cases, and a survival of about 10-12 months.
Venetoclax-azacitidine combination therapy induces programmed tumor cell death and has synergistic activity with hypomethylating agents. In the Viale-A study of over 400 newly diagnosed patients ineligible for intensive chemotherapy, combined venetoclax-azacitidine treatment was more effective than azacitidine alone, with a median overall survival of 14.7 months compared with 9.6 months for azacitidine alone.
In addition, complete remission achieved with venetoclax plus azacitidine was two times higher (66%) than with azacitidine alone (28.3%). About half of the patients treated with venetoclax plus azacitidine achieved complete disease remission before starting the second cycle, with a median duration of response of 17.5 months.
Long-term follow-up of the study confirmed this survival benefit, with a 42% reduction in the risk of death. These results have significant clinical significance, as for the first time complete remissions can be achieved without resorting to chemotherapy.
Giuseppe Toro, National President of AIL (Italian Association against Leukemia, Lymphoma and Myeloma), underlined the importance of timely management of the haematological patient and the need for increasingly integrated and multidisciplinary assistance, which includes the psychologist, the nutritionist, the palliative specialist in infectious diseases, to ensure rapid and uniform access to innovation and social-health support services in the area.
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