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    Home > Active Ingredient News > Drugs Articles > J & J lymphoma drug imbruvia approved by FDA

    J & J lymphoma drug imbruvia approved by FDA

    • Last Update: 2013-11-14
    • Source: Internet
    • Author: User
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    Source: Biovalley announced on November 13, 2013 that the FDA has approved the blood cancer drug ibrutinib (proposed trade name is imbruvica) for the treatment of adult patients with mantle cell lymphoma (MCL) who have previously received at least one other drug (such as celgene's Revlimid) The drug has become the second drug approved by FDA breakthrough therapy, and ibrutinib will become the first Btk targeted drug on the market The FDA approved Roche's gazyva earlier this month for the treatment of chronic lymphoblastic leukemia (CLL), the first drug approved by the FDA for breakthrough therapy In the United States, mantle cell lymphoma (MCL) accounts for 6% of non-Hodgkin's lymphoma cases At the time of diagnosis, MCL usually spreads to lymph nodes, bones and other organs At present, ibrutinib is also waiting for FDA approval for CLL Some analysts thought the FDA would approve ibrutinib for MCL and CLL at the same time Michael Yee, an analyst at RBC Capital Markets, estimates that ibrutinib's long-term annual global sales will reach $5 billion Ibrutinib, developed by Janssen in collaboration with pharmacyclics, is currently being investigated for treatment of several types of blood cancer On July 10 and October 30 this year, J & J submitted to FDA and European Drug Administration (EMA) an application for marketing authorization (MAA) of ibrutinib, seeking approval for the treatment of adult patients with recurrent or refractory chronic lymphoblastic leukemia (CLL) / small lymphoblastic leukemia (SLL) or recurrent or refractory mantle cell lymphoma (MCL) CLL / SLL and MCL belong to a group of blood cancers called B-cell malignancies Many patients will relapse after treatment and may use several drugs during the treatment About ibrutinib: ibrutinib is the first new drug called the inhibitor of Bruton tyrosine kinase (Btk) Btk is an important protein involved in the regulation of B cell maturation and survival In malignant B cells, B cell receptor signaling pathway is over active, which includes Btk Ibrutinib can form a strong covalent bond with Btk, thus inhibiting the transmission of over active cell survival signals in malignant B cells
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