| January 24, 2011 | By Severina Cantaron |
The approval is based on data from the Phase III study that nilotinib has ENESTnd shown to overcome imatinib significantly higher percentage in getting molecular response not only increased but also complete and in a significant reduction in disease progression.
After the introduction of imatinib in 2001, the availability of nilotinib in the first line represents a new paradigm in the treatment of chronic myeloid leukemia (CML). This milestone marks a further step in the path toward the cure of the disease.
What 'nilotinib'
It 's a potent and selective inhibitor of Bcr-Abl protein that causes the production of cancer cells in Ph + chronic myeloid leukemia. The profound reduction of this protein, defined as major molecular response and complete, represents a milestone for the long-term disease control in patients with Ph + chronic myeloid leukemia.
"The follow up to 24 months confirmed that treatment with this drug to ensure greater molecular responses of 62% compared to 37% of imatinib, and nilotinib for the complete molecular responses reached 26% compared to 10% of imatinib "said Giuseppe Saglio, Professor of Internal Medicine and Hematology, University of Torino, Ospedale Universitario S. Luigi Gonzaga di Orbassano. The data also showed the ability to reduce disease progression to accelerated phase or blast already 12 months old, which is what interests us most for the treatment of disease. This finding was confirmed at 24 months. "
chronic myeloid leukemia
And 'one of the four most common types of leukemia. Its precise incidence is uncertain in the absence of a national registry, but it is estimated that the present cases in Italy, are now 6-7 thousand each year to which were added about 700-800 new.
"With the introduction of new therapies and the mortality decreased to about 2% per year and therefore every 5-6 years, the number of patients doubles and progressively increase the patients living with disease and drug-dependent for life," says Michele Baccarani, Professor of Hematology University of Bologna, Director of the Institute of Hematology and Lorenzo Serà gnoli Ariosto. "These issues present challenges in terms of organization of life for patients but also healthcare and pharmaceutical expenditure."
"Be prepared to provide the therapies that are able to 'wean' patients from the treatment without provoking a revival of the disease is very important. Not only for patients but also for the health system, "adds Saglio. "This process is now accelerated with the introduction of nilotinib because a greater proportion of patients could achieve that goal."
"We've stemmed the damage the disease could give patients and we saved and now we have set ourselves the aim of saving patients that they should not depend on the therapy for life, "concludes Baccarani.
I 'care plans'
The project "Path to care " Novartis' efforts to provide a better understanding of the disease, the standardization of the method of measuring the response to therapy and to define new approaches for the comprehensive management of chronic myeloid leukemia.
This includes unique activities of collaboration with academic and scientific institutions at national and European level, such as the Labnet project in collaboration with GIMEMA (Italian Group for Adult Hematologic Diseases) and EUTOS in collaboration with the European LeaukemiaNet. With the project
Labnet, has established a network of over 20 molecular biology laboratories that are based on international methodology and shared that rely on a single web-based platform to measure the response to therapy.
EUTOS The European project, but has the goal of creating a register patients at the European level, to ensure standardization of response to treatment and education of doctors continues. The Italian hospitals involved in the project are 100 distributed all over the country. Bologna, Turin and Naples are the laboratories reference. Bologna is also the scientific references for the creation of the European registry.
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