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besponsa approval history

besponsa approval history

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besponsa approval history
Besponsa (inotuzumab ozogamicin) FDA Approval History , About BESPONSA® | BESPONSA®, Besponsa | European Medicines Agency, Welcome to BESPONSA® | BESPONSA®, Besponsa for Acute Lymphoblastic Leukemia Approved by FDA, FDA Approves BESPONSA - ACCP, Inotuzumab ozogamicin - Wikipedia, BESPONSA® approved in the EU for adult patients with , FDA approves new treatment for adults with relapsed or .
Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include IBM Watson Micromedex (updated 1 May 2019), Cerner Multum™ (updated 2 May 2019), Wolters Kluwer™ (updated 1 May 2019) and others.. Besponsa Approval History. Company: Pfizer Inc. Besponsa (inotuzumab ozogamicin) is a CD22 monoclonal antibody and calicheamicin cytotoxic agent conjugate for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).. BESPONSA is a type of medicine called an antibody-drug conjugate. BESPONSA is designed to find and attach to a specific protein, called CD22, found on leukemia cells BESPONSA is designed to find and attach to a specific protein, called CD22, found on leukemia cells.
Besponsa is a cancer medicine used to treat a type of blood cancer which affects B cells (a type of white blood cells) called B-cell precursor acute lymphoblastic leukaemia (ALL).. The Food and Drug Administration approved BESPONSA based on the results of the clinical trial that showed treatment with BESPONSA compared to chemotherapy improved complete remission (CR) rates (36% vs 17%), length of CR (8.0 months vs 4.9 months), and minimal residual disease–negative CR rates (90% vs 32%).. Pfizer Inc. announced that the FDA has approved Besponsa (inotuzumab ozogamicin) for treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).. On August 17, 2017, the U.S. Food and Drug Administration (FDA) approved BESPONSA (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).. In 2017 inotuzumab ozogamicin was approved by the European Commission and the FDA for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in 2017 under the trade name Besponsa (Pfizer/Wyeth).. Details Pfizer 07 July 2017 Pfizer Inc. (NYSE:PFE) announced that the European Commission has approved BESPONSA® (inotuzumab ozogamicin) as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL)..
 
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