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besponsa ema approval

besponsa ema approval

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besponsa ema approval
Besponsa - European Medicines Agency - ema.europa.eu, EMA Issues Positive Opinions for Four Cancer Drugs in , Besponsa, INN - inotuzumab ozogamicin - ema.europa.eu, Welcome to BESPONSA® | BESPONSA®, Besponsa (inotuzumab ozogamicin) FDA Approval History , BESPONSA - inotuzumab ozogamicin - ema.europa.eu, Besponsa New FDA Drug Approval | CenterWatch, BESPONSA® Approved in the EU for Adult Patients with , FDA approves new treatment for adults with relapsed or .
The EMA adopted a positive opinion recommending approval of the anti-CD22 antibody inotuzumab ozogamicin (BESPONSA®, Pfizer Limited) for use as monotherapy for treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). Patients with Philadelphia-chromosome positive (Ph+) ALL should have received treatment with at least one prior tyrosine kinase inhibitor (TKI). The recommendation for approval is based on results from the in which treatment with inotuzumab ozogamicin resulted in significantly higher rate of complete remission (80.7% vs 29.4%; P<.001) and longer progression-free survival and overall survival compared to standard chemotherapy. Veno-occlusive liver disease was a major adverse event associated with inotuzumab ozogamicin.. 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 EMA adopted a positive opinion recommending approval of the anti-CD22 antibody inotuzumab ozogamicin (BESPONSA ®, Pfizer Limited) for use as monotherapy for treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). Patients with Philadelphia-chromosome positive (Ph+) ALL should have received treatment with at least one prior tyrosine kinase inhibitor (TKI). The recommendation for approval is based on results from the.
Besponsa EMA/269417/2017 Page 2/3 Patients in whom Besponsa works well should receive 2 or 3 cycles, after which they can have a stem cell transplant to replace their bone marrow , the only curative treatment.. 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%).. 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).. EMA/CHMP/245560/2017 . Committee for Medicinal Products for Human Use (CHMP) Summary of opinion. 1 (initial authorisation) Besponsa . inotuzumab ozogamicin . On 21 April 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a . marketing authorisation for the medicinal product Besponsa, intended for the treatment of adults with . Besponsa (inotuzumab ozogamicin) is a CD22-directed antibody-drug conjugate (ADC). Besponsa is specifically indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.. “The approval of BESPONSA (inotuzumab ozogamicin) provides a much needed treatment option for physicians and patients alike, that may help improve outcomes for some of the most vulnerable .
 
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