The new pharmaceutical form of ibrutinib, Bruton’s tyrosine kinase inhibitor (Btk), for the treatment of chronic lymphocytic leukemia, mantle cell lymphoma and Waldenström macroglobulinemia. The new film-coated tablet formulation, compared to the previous capsule formulation, allows a single daily administration for all three indications. In addition, based on the latest studies, ibrutinib is now also available for patients with chronic lymphocytic leukemia under the age of 65. He announces it in a note Janssena Johnson & Johnson Group pharmaceutical company that manufactures the drug.
In detail, the new pharmaceutical formulation of ibrutinib, in the therapeutic indications for chronic lymphatic leukemia and Waldenström macroglobulinemia, provides switch from 3 capsules of 140 mg each to a single 420 mg tablet per day. As for mantle cell lymphoma, however, the transition is from 4 capsules to a single 560 mg tablet, always per day. Chronic lymphatic leukemia – the note recalls – is the most frequent form of leukemia among adults in Western countries and accounts for 30 percent of all leukemias. In Italy there are an estimated 1,600 new cases each year among men and 1,150 among women. It is a predominantly typical disease in the elderly, however, 15% of cases are diagnosed before the age of 60. In more than half of patients, the disease is diagnosed by chance, during routine examinations. As the disease evolves, nonspecific symptoms may occur, also typical of other forms of leukemia.
Mantle cell lymphoma and Waldenström macroglobulinemia – rarer lymphoproliferative diseases that correspond to 2-10% of all lymphomas and 2.5 cases per 1 million people respectively – are also found occasionally. Symptoms, when present, are highly variable, common to other lymphoproliferative disorders or closely related to the characteristics of the monoclonal component, in the case of Waldenström’s disease. The daily administration of a single tablet represents a milestone in the treatment of these neoplasms, the ultimate result of which is to improve therapeutic adherence to the drug, as well as the quality of life for patients suffering from typical diseases of the elderly.
“The Italian Association against leukemia, lymphomas and myeloma – says Matilde Cani, head of office and institutional projects – Ail, section of Milan – for over 50 years has been alongside hematological patients with the aim of supporting research, and raise public awareness against blood cancers. In recent years, in fact, the extraordinary advancement of scientific research and increasingly effective treatments have increased not only the duration but also the quality of life of patients. Ail, through the work of its 82 provincial sections, is helping to treat patients in the best possible way “.
Ibrutinib, both as monotherapy and in combination with other molecules – continues the note – has shown a significant benefit in terms of sustained efficacy in multiple phase 3 studies, which have led to a significant paradigm shift in the treatment of newly diagnosed affected patients. from chronic lymphatic leukemia, replacing the treatments hitherto considered standard in the young patient, namely chemotherapy regimens such as Fcr (fludarabine, cyclophosphamide and rituximab).
In particular, the pivotal phase 3 study (Ecog1912), compared ibrutinib, in combination with rituximab (I + R), compared to the Fcr combination, on 529 fit patients (i.e. those patients who do not have disabilities or comorbidities and therefore candidates for a standard treatment, ed) and under the age of 70 with newly diagnosed chronic lymphocytic leukemia. The study represents the first comparison between ibrutinib, in combination with rituximab, versus Fcr, as first-line therapy in fit and younger patients aged 65 years.
Median progression-free survival, the primary endpoint of the study, was statistically superior in the I + R arm compared to the Fcr arm, in patients with or without the Ighv gene mutation. In addition, a prolonged improvement in overall survival (Os) compared to Fcr was observed in the I + R arm, especially in the patient with the Ighv gene mutation, also demonstrating that the patient who does not discontinue treatment obtains a sustained and prolonged response over time. .
The drug is now also available for people with chronic lymphocytic leukemia under the age of 65. “The results of study E1912, with a follow-up of 6 and a half years, are added to those of other studies in which Ibrutinib demonstrates superiority over more commonly used chemoimmunotherapy regimens and which guarantee us to be able to use it, in the first line of treatment, even in patients with CLL under the age of 65 – explains Paolo Ghia, professor of medical oncology, Vita-Salute San Raffaele University -. The significant advantage in terms not only of disease-free survival, but also of overall survival, allows us to offer a new therapy option even in younger patients with good performance status. In addition, the new oral tablet formulation could help to improve adherence to therapy and therefore, to replicate the results obtained in clinical trials also in clinical practice “.
“For over 30 years Janssen Oncology has invested in scientific research for the development of innovative drugs that meet the care needs of patients and to support doctors in the treatment of solid and haematological cancers, such as chronic lymphatic leukemia, mantle cell lymphoma and Waldenström’s macroglobulinemia – says Danilo Arienti, Therapeutic Area Hematology Medical Manager Janssen Italia -. The new formulation of ibrutinib, as well as the extension of availability for patients under 65 in chronic lymphatic leukemia is a further step forward in the definition of non-chemotherapy oncological therapies in Italy, a commitment of Janssen that has become one of the cornerstones of our mission ” .
#Blood #tumors #Italy #Ibrutinib #single #dose #mouth