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GLG News by Hematologists and Oncologists in Private Practice (US)

Analysis of: One drug, many uses. Good idea? (www.indystar.com)
The public benefits when new uses are found for old drugs.  The benefit comes more quickly as the pharma company does not need to go through as many early studies to allow the approval for the drug use. However, I believe that pharma realizes that new uses for old drugs is not the way...
Analysis of: New Study Probes Safety of Erythropoiesis-Stimulating Agents (www.medscape.com)
Use of Epo Stimulating Agents (ESAs) for cancer patients have all but come to a screeching halt when a plattoon of studies came out suggesting that ESAs might actually cause more harm, notably by possibly acting as a growth factor for tumor cells.  Now, reserachers are trying to determine...
Analysis of: Transgene's Therapeutic Vaccine TG4010 Meets Primary Endpoint in Non-Small Cell Lung Cancer Phase IIb Trial (www.pipelinereview.com)
Transgene's TG4010 vaccine has a fairy elegant two-gene design.  It appears to add benefit to a standard chemo regimen in this good-sized, randomized Phase II study for advanced lung cancer.  More mature survival data will be ready by year's end.  Phase III study is being planned.  ...
Analysis of: Positive data on Antisoma’s ASA404 presented at ASCO (www.pipelinereview.com)
Adding novel biologic agents (such as ASA404) to traditional chemotherapy is a very hot trend in cancer research.  The data from Antisoma's lung cancer study are certainly intriguing, but again, phase II, and retrospective. 
Analysis of: Initial safety report of NSABP C-08, a randomized phase III study of modified 5-fluorouracil (5-FU)/leucovorin (LCV) and oxaliplatin (OX) (mFOLFOX6) with or without bevacizumab (bev) in the adjuvant treatment of patients with stage II/III colon cancer. (www.abstract.asco.org)
While chemo plus Avastin is the standard of care for first treatment of advanced colon cancer, chemotherapy alone is used for most early colon cancer. This large study demonstrates the relative safety of adding Avastin to chemo in the early - adjuvant – setting.
Analysis of: Continuing Herceptin treatment prevents disease progression in women with aggressive metastatic breast cancer (www.pipelinereview.com)
Many of us oncologists have been in the practice of continuing  Herceptin (Trastuzumab) even when the breast cancer we were treating was growing while on the drug.  Now, this randomized study gives data to back up that practice.
Analysis of: New data on MAGE-A3 cancer immuno therapy support novel options of treating non-small cell lung cancer and melanoma (www.pipelinereview.com)
This describes a potential two-step process using modern molecular biology to customize cancer therapy. First the Affymetrix Microarray analyzes tumor genes to try to identify which patients are at high risk to have a cancer recurrence following lung cancer surgery. Second, Glaxo's MAGE-A3 proprietary...
Analysis of: FDA says Glaxo drug fails to control bleeding (seattletimes.nwsource.com)
Apparently, the FDA was not impressed enough with the data for Promacta (eltrombopag) for the treatment of ITP, a common and potentially serious auto-immune bleeding disorder involving platelets.  Citing a lack of "robust evidence" from several studies, the FDA will be seeking further opinions...
Brian Abbott, MD, Medical Director of Hematology
Brian Abbott, MD, Medical Director of Hematology
Big Sky Oncology
Analysis of: FDA Accepts TREANDA(R) New Drug Application for the Treatment of Relapsed Indolent Non-Hodgkin's Lymphoma (www.pipelinereview.com)
The ease of use compared to fludarabine regimens, and the superior efficacy vs chlorambucil, puts TREANDA in the sweet spot for potential front-line use in CLL.
Brian Abbott, MD, Medical Director of Hematology
Brian Abbott, MD, Medical Director of Hematology
Big Sky Oncology
Analysis of: Look to England's example for ways to solve America's health-care problem (www.sltrib.com)
National healthcare has again become part of the presidential election dialog, after a curious 12+ year absence. Also curious, Hillary Clinton is again center stage in the discussion. Will the outcome be different this time?

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