ROMA (ITALPRESS) – Lilly announces that the Italian Pharmaco Agency (AIFA) has approved the repayment of pirtobrutinib for the treatment of adult patients suffering from chronic lymphatic leukemia (LLC) relapse or refractory. The decision, published in the Official Journal on 26 March 2026, makes the drug available for patients who have previously been treated with a covalent inhibitor of tyrosine kinase of Bruton (BTK). LLC is a blood tumor characterized by an accumulation in peripheral venous blood and lymphocyte organs B. In the early stages, the disease develops as proliferation of “clonal” cells, i.e. identical copies of the pathological lymphocytes concerned, to which it follows the involvement of lymphatic structures – lymph nodes and spleen – which increase in size.
In the West, LLC is the most frequent form of leukemia in adults and the incidence is estimated in 5 cases every 100,000 people. Around 3000 new cases per year are estimated in Italy. The disease is typical of the most advanced age, with 40% of the diagnosis carried out over 75 years and only 15% within 50 years. The average age at diagnosis is about 70 years, with a slight prevalence of men compared to women 1 .
Despite therapeutic progress, many patients with LLC meet multiple relapses or become resistant to treatment. Pirtobrutinib represents a significant therapeutic innovation, as it acts as a non-covalent BTK inhibitor and is able to bind to the target protein differently than the covalent inhibitors of first and second generation.
“In Sicily, more than 200 new diagnosis of chronic lymphatic leukemia is estimated every year. In this context, the approval of the repayment of pirtobrutinib marks an important therapeutic advancement for patients with relapsed or refractory LLC”, commented Caterina Patti, Director U.O.C. of Oncoematology and Director Department of Oncoematology of Hospitals Reunited Villa Sofia – Cervello (Presidio V. Cervello). “ Its value lies in the ability to act with a unique and reversible mechanism of action, thanks to which it is able to overcome the molecular resistances that develop during previous treatments.”
The results of the trial phase 1/2 BRUIN, published in the New England Journal of Medicine in 2023, showed the effectiveness of the drug in a population of highly pretreated patients, showing lasting clinical responses even in cases of unfavorable prognosis. Phase 3 CLL- BRUIN 321 3 then compared pirtobrutinib with the standard treatment of reference in the same setting, demonstrating its superiority of effectiveness. “The clinical evidence has shown the effectiveness of pirtobrutinib in patients with recurrent or refractory LLC that have developed resistance or intolerance to BTK covalent inhibitors,” said Professor Patti. “This is a new and concrete therapeutic opportunity, capable of contributing to the control of the disease with a very manageable safety profile. For us clinical, being able to count on this new option means having an extra tool for more flexible and personalized management of the therapeutic path, with the aim of maintaining longer the control of the disease and preserving the quality of life of patients”.
Since October 2024, pirtobrutinib is reimbursed in Italy in the treatment of adult patients suffering from mantellar cell lymphoma (MCL) recurrent or refractory previously treated with a BTK inhibitor. To which the indication in the LLC is added. “We are proud to be able to make pirtobrutinib available for this population of hematologic patients,” says Elias Khalil, Chairman and CEO of Italy Hub of Lilly. “This new approval reflects our constant commitment to oncological innovation and research intosolutions that can really make a difference for people with rare or complex tumors.”.
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