Janssen-Cilag International NV has filed an application for approval of type II to the European Medicines Agency (EMA) to obtain the amplification of the authorisation on the market of Imbruvica (Ibrutinib) and include a new therapeutic indication for the treatment of adult patients with Waldenstrom's macroglobulinemia (MW). If approval is obtained, it will extend the indications Imbruvica a third type of blood cancer. WM is a rare type of lymphoma B cell.
Imbruvica is one of the first inhibitors of Bruton's tyrosine kinase (BTK) in its category, administered once a day orally. Imbruvica is co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies group) and Pharmacyclics Switzerland GmbH. Subsidiaries Janssen Imbruvica market in EMEA ( Europe , Middle East, Africa) and in the rest of the world, except the United States where the two companies jointly market the.
"At Janssen , we dedicated to developing innovative products to extend and improve the lives of patients, "said Thomas Stark , Vice President Medical Affairs at Janssen EMEA. "This additional application of Imbruvica, in the treatment of Waldenstrom's macroglobulinemia is an important milestone in the treatment of patients with this disease for which there is currently only limited treatment options in Europe . If approval is obtained, Imbruvica has the potential to address the unmet needs of patients with this blood cancer difficult to treat. Do you even lift The MW (also known under the name lymphoplasmacytic lymphoma secreting IgM immunoglobulin) is a rare type of cancer and slow blood to grow. It is characterised by a proliferation in B cells , a type of white blood cell (lymphocyte) produced by the bone marrow. The median age of patients diagnosed is 63 to 68 years, and the prevalence rate of disease in men and women in Europe is about 7.3 and 4.2 per million people, respectively. To date, the MW remains an incurable disease.
In October 2014, Imbruvica received approval from the European Commission for the treatment of adult patients with mantle cell lymphoma (MCL) relapsed or refractory, or adult patients with chronic lymphocytic leukaemia (CLL) who received at least previous treatment, or as a first-line treatment in case of deletion 17p or TP53 mutation in patients unsuitable for chemo-immunotherapy. Janssen and Pharmacyclics continue to deploy their vast Imbruvica development programme that includes commitments to phase III trials across multiple patient populations.
Imbruvica (Ibrutinib) is a tyrosine kinase inhibitor of Bruton (BTK), which form a strong covalent bond with the BTK to block transmission of cell survival signals in malignant B cells. By blocking this BTK protein , Imbruvica helps suppress and reduce the number of cancer cells. It also slows down the development of cancer.
In October 2014, Imbruvica received approval from the European Commission for the treatment of adult patients with mantle cell lymphoma (MCL) relapsed or refractory, or adult patients with chronic lymphocytic leukemia (CLL) who received at least previous treatment, or as a first-line treatment in case of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. This approval allows the placing on the market Imbruvica in 28 countries 'European Union.
In November 2013, Imbruvica has received approval from the US Food and Drug Administration (US FDA) for the treatment of patients with MCL who have received at least one treatment , and in February 2014, under the approval condition for the treatment of CLL in patients who have received at least one treatment. The regulatory approval for the treatment of CLL was issued in July 2014, including the approval of the drug as a treatment first-line therapy in patients with 17p deletion. On October 20, 2014, an additional authorisation for placing on the market (sNDA) to Imbruvica was filed with the FDA. also Imbruvica Israel approved for the treatment of adult patients with LCM or LLC and who have received at least one treatment, and Switzerland for the treatment of adult patients with LCM, which differs from other lymphomas by chromosome translocation t , and / or overexpression of cyclin D1, for which no partial response was obtained during a previous treatment, or who have shown an increase following a first treatment.
Experimental use of Ibrutinib, alone or in combination with other treatments, is underway on several blood cancers including CLL, MCL, Waldenstrom's macroglobulinemia (MW), diffuse large B-cell lymphoma (DLBCL) , follicular lymphoma (FL) and multiple myeloma (MM). Imbruvica is approved for the treatment of CLL and MCL. The regulatory approval for additional uses has not yet been issued.
The MW (also known under the name lymphoplasmacytic lymphoma secreting IgM immunoglobulin) is a cell lymphoma type B rare and incurable slow development for which there is no established treatment, or approved in the EU. The median age of patients diagnosed is 63 to 68 years, and the disease prevalence among men and women in Europe is about 7.3 and 4.2 per million people, respectively. The MW begins with the transformation of B cells, a type of white blood cells (lymphocytes) in malignant cells, which during their maturation continue to reproduce for other malignant B cells. WM cells produce large amounts of immunoglobulin M antibodies, or IgM. Normally, IgM antibodies help the body fight infections. Excess IgM cause the blood to thicken and are causing various symptoms of the MW, such as bleeding, vision and nervous system disorders.