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GLG News by Rituxan Prescribers for NHL: Lymphoma Oncologists (US)

Analysis of: Wyeth Cancer Drug Torisel Gets European Commission Approval (www.therapeuticsdaily.com)
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...
Analysis of: Avastin receives positive opinion in Europe for first-line treatment of patients with advanced kidney cancer (www.pipelinereview.com)
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...
Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Analysis of: Pharmexa provides update on the HeptoVax trial of GV1001 in liver cancer (www.pipelinereview.com)
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...
Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
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)
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...
Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Analysis of: Hana Biosciences Initiates Marqibo Phase 2 Clinical Trial in Metastatic Malignant Uveal Melanoma (www.pipelinereview.com)
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...
Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Analysis of: Avastin receives positive opinion in Europe for first-line treatment of patients with advanced kidney cancer (www.pipelinereview.com)
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...
Analysis of: Amgen Spends Big Protesting Curbs On Anemia Drugs (online.wsj.com)
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,...
Analysis of: Major Phase 3 Trial Shows Zevalin(R) Extends Progression-Free Survival in one of the most common types of Lymphoma (www.pipelinereview.com)
Bayer's Zevalin showed efficacy as single dose in first line consolidation treatment of patients with follicular lymphoma. These impressive results will have little impact on Zevalin's use since this radio-labeled antibody had to be administered in specialized nuclear medicine setting which is not available...
Analysis of: Avax initiates Phase III registration trial for metastasis vaccine (www.therapeuticsdaily.com)
Avax's M-Vax vaccine will be tested in a randomized Phase III trial , together with other immunomodualtors, in 387 patients with metastatic melanoma. The study is well designed with specific end points and good sample size. Earliest efficacy data would be in late 2009. This vaccine has a good potentail...
Analysis of: IDM Pharma Announces Updated Phase 2 UVIDEM(R) Results Showing Durable Disease Control and Tolerability in Advanced Melanoma Patients (www.pipelinereview.com)
IDM's dendritic cell-based vaccine produced 30 %" clinical benefit" in a phase II trial of 33 patients with"low volume"  metastatic melanoma with long duration of responses ( 7.2 to 29.7 months) These are impressive results even in this " favorably selected" patient poulation. Other therapies being...

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