FDA approved Velcade for multiple myeloma (mm) retreatment
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Last Update: 2014-08-11
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Source: Internet
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Author: User
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Source: Takeda and its subsidiary Millennium announced on August 9, 2014 that Velcade (universal name: Bortezomib) has been approved by FDA for multiple myeloma (multiple myeloma) that once responded to the treatment of Vanke and had relapsed at least 6 months after the last treatment of Vanke Mm) adult patients' relapse Velcade's product label update includes medication guidelines and safety and efficacy data when Velcade is used as a single drug or in combination with dexamethasone for the retreatment of Velcade treated patients Velcade retreatment can begin at the tolerable dose of the last treatment Velcade has previously been approved for the treatment of multiple myeloma (mm) and mantle cell lymphoma (MCL), which has previously received at least one treatment FDA approved Velcade's Supplemental new drug application (SNDA) for retreatment, including a phase II study and other supporting data This phase II international review study showed that the overall remission rate (ORR) of patients with multiple myeloma (mm) who had previously received Velcade treatment and achieved partial or complete remission after Velcade treatment was 38.5% In this study, the safety of Velcade retreatment was consistent with that of the known intravenous injection of Velcade in the treatment of recurrent multiple myeloma (mm) The most common adverse drug reaction in the study was thrombocytopenia, which occurred in 52% of patients In the past 11 years, Velcade has played an important role in the clinical treatment of multiple myeloma (mm) as the only drug that has been proven to delay the overall survival time (OS) of newly diagnosed or relapsed MM patients Velcade's newly approved drug delivery guidelines will enable doctors to continue to provide this effective drug treatment for their Velcade treated patients and use Velcade in the whole clinical care area of multiple myeloma About Velcade: Velcade is jointly developed by Takeda and Johnson & Johnson Takeda is responsible for the commercialization of the drug in the United States Johnson & Johnson is responsible for the commercialization of the drug in Europe and other parts of the world In Japan, Takeda and Johnson & Johnson jointly promote the drug At present, Velcade has been approved by more than 90 countries around the world, and the total number of patients treated with the drug has exceeded 550000.
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