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GLG News by Oncologists Specializing in Hematologic Malignancies in the U.S.

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December 3, 2007
Erbitux is consolidating its position in treatment of advanced colrectal cancer
Analysis of: New Data Highlight That Treatment With Erbitux Allows More Resections of Preteated Patients With Metastatic Colorectal Cancer | www.pipelinereview.com
Author: GLG Expert Contributor
A new French study shows that Erbitux allowed 9 of 133 pre-treated patients with colrectal cancer and liver mets to have their liver lesions become resectable. While the numbers of responding patients is small, this has huge implications since surgical resection od liver lesions may incraese survival...
November 28, 2007
Torisel for renal cell cancer: efficacy with favorable safety profile
Analysis of: Wyeth Cancer Drug Torisel Gets European Commission Approval | www.therapeuticsdaily.com
Author: GLG Expert Contributor
The EU followed the FDA in approving Wyeth's Torisel for advanced renal cell cancer. It prolonged overall and Progression-free survival as compared to interferon in a randomized trial. Torisel has a different side effect profile than Sutent ( Pfizer) and Nexavar( Bayer/Onyx) so it is expected to be...
November 28, 2007
Avastin in renal cell carcinoma: role is in comination with oral agents
Analysis of: Avastin receives positive opinion in Europe for first-line treatment of patients with advanced kidney cancer | www.pipelinereview.com
Author: GLG Expert Contributor
Avastin was approved in Europe for use in advanced renal cell carcinoma in combination with interferon Unlike Nexavar, Sutent, or Torisel which have showed survival adavantage as single agents, Avastin has not. The role of Avastin in this disease will be in combination therapy with any of above 3 targeted...
November 26, 2007
HeptoVax Trial Not Interpretable Yet
Analysis of: Pharmexa provides update on the HeptoVax trial of GV1001 in liver cancer | www.pipelinereview.com
Author: Michael Grossbard, Professor of Clinical Medicine, Columbia University College of Physicians and Surgeons
The HeptoVax trial is  Phase II study in which GV1001 (a telomerase peptide vaccine administered with GM-CSF) was given to patients suffering from advanced hepatocellular carcinoma (HCC or liver cancer). The trial update indicates safety of the vaccine but no efficacy data are available.  Such...
November 26, 2007
Erbitux On a Roll
Analysis of: New England Journal of Medicine Study Shows ERBITUX(R) Improves Survival in Advanced Colorectal Cancer | www.pipelinereview.com
Author: Michael Grossbard, Professor of Clinical Medicine, Columbia University College of Physicians and Surgeons
The current report in NEJM demonstrates that Erbitux + best supportive care improves survival (6.1 months) for patients with previously treated metastatic colorectal carcinoma as compared with BSC alone (4.6 months).  These data represent the first report of a survival advantage in a solid tumor...
November 26, 2007
Uveal Melanoma: Can Marqibo Hit a Home Run?
Analysis of: Hana Biosciences Initiates Marqibo Phase 2 Clinical Trial in Metastatic Malignant Uveal Melanoma | www.pipelinereview.com
Author: Michael Grossbard, Professor of Clinical Medicine, Columbia University College of Physicians and Surgeons
Uveal melanoma is an uncommon disease but is devastating when it metastasizes.  The most common site of metastases is the liver and response rates to conventional chemotherapy agents are poor.   This trial is designed specifically to assess the activity of Marqibo in patients with metastatic...
November 26, 2007
Avastin Approval for Renal Cell Carcinoma: Better than Sutent?
Analysis of: Avastin receives positive opinion in Europe for first-line treatment of patients with advanced kidney cancer | www.pipelinereview.com
Author: Michael Grossbard, Professor of Clinical Medicine, Columbia University College of Physicians and Surgeons
Avastin now has been approved in Europe for the treatment of metastatic renal cell carcinoma.  Avastin + Interferon nearly doubles the PFS vs Interferon alone.  Approval in Europe (and similar FDA approval) will be critical to the marketing of this expensive agent.  However, these data...
Brian AbbottNovember 19, 2007
The Vidaza survival benefit news is a positive for MGI Pharma's Dacogen
Analysis of: Vidaza vs Dacgoen for MDS | www.newratings.com
Author: Brian Abbott, Medical Director of Hematology, Big Sky Oncology
There is no reason to believe Dacogen is inferior to Vidaza. In some studies, Dacogen seems to produce a deeper quality of response, and may also prove more beneficial in AML.
Brian AbbottNovember 19, 2007
Revlimid benefits seem overstated in non-5Q minus MDS
Analysis of: Phase II study of lenalidomide in transfusion-dependent, low- and intermediate-1-risk myelodysplastic syndromes with karyotypes other than deletion 5q | bloodjournal.hematologylibrary.org
Author: Brian Abbott, Medical Director of Hematology, Big Sky Oncology
Revlimid benefits are often over-stated in non-5Q minus MDS. The cost is a hurdle for many patients with poor prescription plans. Vidaza and Dacogen seem superior in my experience for higher risk patients.
November 16, 2007
Amgen is fighting a losing battle against a fair Medicare decision
Analysis of: Amgen Spends Big Protesting Curbs On Anemia Drugs | online.wsj.com
Author: GLG Expert Contributor
Amgen and to a lesser degree JNJ are lobbying cancer patients to fight Medicare's restriction on their ESA products Aranesp, Epogen and Procrit. The Medicare rule and FDA warnings are fair since using ESA's to increase hemoglobin levels. 12 grams/dl was associated with incraesed mortality, tumor progression,...

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