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besponsa launch date

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besponsa launch date
Pfizer Receives U.S. FDA Approval for BESPONSA , Besponsa | European Medicines Agency, BESPONSA® Approved in the EU for Adult Patients with , BESPONSA 1 mg powder for concentrate for solution for , FDA approves new treatment for adults with relapsed or , Inotuzumab ozogamicin – SPS - Specialist Pharmacy Service , Lisa O’Neill (Europe) - SFJ Pharmaceuticals Group, Besponsa for Acute Lymphoblastic Leukemia – Details | CADTH.ca, Global Besponsa Market 2018 by Manufacturers, Regions .
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. . BESPONSA is the first and only CD22-directed antibody-drug conjugate indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BESPONSA® (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1 BESPONSA was reviewed and approved under the FDA’s Breakthrough . Besponsa is given as an infusion (drip) into a vein lasting for at least one hour. The infusions are given on days 1, 8 and 15 of a 3 or 4 week treatment cycle. The doctor may interrupt treatment or reduce the dose, if the patient develops certain serious side effects..
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.. f In the standard definition of PFS, defined as the time from date of randomisation to earliest date of the following events: death, progressive disease (including objective progression and relapse from CR/CRi), the HR was 0.568 (2-sided p-value=0.0002) and median PFS was 5.6 months and 3.7 months in the BESPONSA and Investigator's choice of chemotherapy arm, respectively.. The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).. The co-primary endpoint of complete remission with incomplete haematologic recovery was achieved by 80.7% of patients treated with inotuzumab ozogamicin, and 33.3% of those given the standard of care, according to preliminary results [11].. ALL. A Biologics License Application (BLA) for BESPONSA for the treatment of adult patients with relapsed or refractory B-cell precursor ALL was accepted for filing and granted Priority Review by the FDA in March 2017. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is August 2017.. ‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback..
 
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