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BESPONSA® Approved in the EU for Adult Patients with , NICE issues decision on Mylotarg, Besponsa for leukaemia , Pfizer’s ADC ambition bolstered by US Besponsa approval, Gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth), BESPONSA® approved in the EU for adult patients with , Besponsa wins FDA approval for relapsed/refractory ALL , Response Rates as Predictors of Overall Survival: A Meta , BESPONSA® Approved in the EU for Adult Patients with , Inotuzumab Ozogamicin versus Standard Therapy for Acute .
This webcast may contain forward-looking statements about, among other things, our anticipated future operating and financial performance, business plans and prospects, in-line products and product candidates, strategic reviews, capital allocation, business-development plans, the benefits expected from the reorganization of our commercial operations into three businesses effective at the beginning of our 2019 fiscal year, our acquisitions and other business development activities, our proposed transaction with GSK to combine our respective consumer healthcare businesses into a new consumer healthcare joint venture, our ability to successfully capitalize on growth opportunities or prospects, manufacturing and product supply and plans relating to share repurchases and dividends, among other things, that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. . This release contains forward-looking information about BESPONSA (inotuzumab ozogamicin), and an approval by the European Commission as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.. The National Institute for Health and Care Excellence has issued draft guidelines backing restricted use of Pfizer’s Mylotarg for newly diagnosed acute myeloid leukaemia (AML), but has asked for more information on the firm’s Besponsa for a type of acute lymphoblastic leukaemia (ALL). - News - PharmaTimes.
Besponsa (inotuzumab ozogamicin), indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, was granted approval from the US Food and Drug Administration (FDA) under its breakthrough therapy designation and priority review programme.. Study AML-19 (NCT00091234) was a multicenter, randomized, open-label Phase III study comparing single agent gemtuzumab ozogamicin (n=118) to best supportive care (n=119) for elderly patients who could not tolerate other AML therapies.. 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).. The FDA has approved inotuzumab ozogamicin (Besponsa) for the treatment of adults with relapsed/refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL). Why this matters Inotuzumab ozogamicin previously was granted breakthrough therapy and orphan drug designations, and underwent priority review for approval.. Discussion. There is an unmet medical need for better therapies for elderly AML patients; however, the use of OS as an endpoint in elderly AML patients may require 2-3 years to demonstrate survival benefit.. BESPONSA is an antibody-drug conjugate (ADC) comprised of a monoclonal antibody (mAb) targeting CD22, a cell surface antigen expressed on cancer cells in almost all B-ALL patients, linked to a .
 
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