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GLG News by Hematologists who Treat Myelodysplastic Syndromes

Analysis of: AstraZeneca Files Marketing Application in Europe for EGFR Inhibitor Gefitinib (IRESSA(TM)) in Locally Advanced Pre-Treated Non-Small Cell Lung Cancer (www.pipelinereview.com)
Approval will be base on the phase III INTEREST trial that showed in NSCLC that Iressa was "non-inferior" to standard chemotherapy after platinum therapy failure first line. Iressa was better tolerated and had an improved quality of life.
Analysis of: New Study Ties Genes To Leukemia Treatment (online.wsj.com)
Gene mutation analysis can help refine therapy in acute leukemia and impact on results!!
Analysis of: Wider Aim for Rituxan Fails (online.wsj.com)
Rituxan failed to improve various parameters and targets in a rather comprehensive study of patients with Lupus.
Analysis of: IL-21 mediates apoptosis through up-regulation of the BH3 family member BIM and enhances both direct and antibody-dependent cellular cytotoxicity in primary chronic lymphocytic leukemia cells in vitro (bloodjournal.hematologylibrary.org)
ZymoGenetic appears to have a biologic that will expedite lymphocytes apoptosis (destruction) when combined with Fludara and Rituxan- 2 standard agents in this rather common & occasional refractory condition.
Analysis of: Oral PBI-1402 Demonstrates Significant Activity in Chemeotherapy-Induced Anemia Phase II Clinical Trial (www.pipelinereview.com)
This non erythropoietin (Epo) product will raise hemoglobin levels and decrease the need for transfusions.
Analysis of: Poniard reports positive results for lung cancer drug (www.cnbc.com)
Doubles survival BUT "comparator" arm is best supportive care. See http://investor.poniard.com/ReleaseDetail.cfm?ReleaseID=306218
Analysis of: Thalidomide Gets Boost in Europe (online.wsj.com)
Thalidomide literally started the improved outlook in MM along with, and followed by Velcade, Revlimid and Stem Cell transplants. To now have increased access in Europe should open up that market eventhough the other agents are in widespread use (I think)
Analysis of: WellPoint likely to follow FDA on anemia drugs (www.reuters.com)
A major insurer (Wellpoint) is using the guidelines of the FDA to restrict erythropoietin (Epo) use.
Donald Fleming, MD, Division Head of Hematology and Oncology
Donald Fleming, MD, Division Head of Hematology and Oncology
Davis Health System, Inc.
Analysis of: Randomized Phase III Study of Capecitabine Plus Oxaliplatin Compared With Fluorouracil/Folinic Acid Plus Oxaliplatin As First-Line Therapy for Metastatic Colorectal Cancer (jco.ascopubs.org)
Xeloda has time after time demonstrated to be as good if not better than 5FU Xeloda continues to lag behind 5FU in the US Recent trial results are not likely to change things overnight
Analysis of: Randomized Phase III Study of Capecitabine Plus Oxaliplatin Compared With Fluorouracil/Folinic Acid Plus Oxaliplatin As First-Line Therapy for Metastatic Colorectal Cancer (jco.ascopubs.org)
In MCRC FOLFOX which involves infusional 5FU has been the cornerstone of therapy. This study shows that an oral 5FU substitute, Xeloda, can replace the IV 5FU and expedide care and avoid cumbersome infusions.

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