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GLG News by ONC-Avastin Prescribers for Colorectal Cancer (US)

Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Analysis of: Amgen Discontinues Trial of Cancer Drug Vectibix (www.therapeuticsdaily.com)
1.  Chemotherapy + Avastin represents standard treatment for stage IV colon cancer.2.  Vectibix has modest activity and increases survival in patients with previously treated stage IV colon cancer3.  When Vectibix is added to Avastin and chemotherpay for stage IV colon cancer, the outcome...
Analysis of: Bayer to File for Nexavar Approval for Liver Cancer (www.therapeuticsdaily.com)
Nexavar continues to expand its place in the oncology arena.Nexavar is approved for renal cell ca and I suspect hepatocellular approval is not far behind.
Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Analysis of: IVREA Pharmaceuticals completes Series A round worth $11 million (www.bioperform.com)
1.  Onchomycosis represents a significant clinical problem thoroughout the United States since nail fungus is cosmetically disfiguring and often uncomfortable.2.  Lamisil and Sporanox, the two existing treatments, require extended therapy and have side effects including hepatotoxicity (both...
Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Analysis of: Xeloda Combination Meets Primary Endpoint in International Phase III Advanced Colorectal Cancer Study (pharmalive.com)
1.  Oxalipatin (or Irinotecan) administered in combination with infusional 5-FU (+/- Avastin) represents the standard of care for the treatment of stage IV colon cancer.2.  The use of infusional 5-FU is cumbersome for patients and clinicians.3.  The current phase II trial demonstrates...
Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Analysis of: Positive Phase II Clinical Trial Results with HER2/neu Vaccine (www.pipelinereview.com)
1.  The E57 peptide, derived from the her2 protein has been used in conjunction with GM-CSF to immunize breast cancer patients to prevent recurrence2.  With 2 year follow up, recurrence rates appear to be lower in vaccinated patients.3.  The design of this trial does not allow for proper...
Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Analysis of: Telik cancer drug fails trials (today.reuters.com)
1.  Telcyte failed to improve survival as compared with Gefitinib in a phase II trial in lung cancer patients.2.  Telcyte failed to improve survival vs. Liposomal Doxorubicin or Topotecan in platinuk resistant ovarian cancer3. Data form a third trial of Telcytemlikely will be uninterpretable.4. ...
Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Analysis of: BioAlliance Gets Green Light For Phase II/III Transdrug Trial (www.therapeuticsdaily.com)
1.  Treatment options for patients with hepatocellular carcinoma remain limited.  Doxorubicin is one standard therapy with response rates of 5-12%.2.  The doxorubicin Transdrug is administered by intraarterial injection and will be assessed in phase II/III trials that evaluate its ability...
Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Analysis of: FDA Grants Torisel NDA Priority Review Status (www.therapeuticsdaily.com)
1.  Despite the introduction of both Sorafenib and Sutent for the treatment of metastatic renal cell carcinoma, new therapeutic options remain needed.2.  Torisel has been granted priority review status by the FDA meaning that FDA approval likely will occur in 2007 for the treatment of...
Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Analysis of: GlaxoSmithKline and Genmab Enter Global Agreement For HuMax-CD20 (pharmalive.com)
1.  HuMax-CD20 is a humanized anti-CD20 antibody that will be developed for the treatment of B-NHL and CLL. This is the same market as Rituxan.2.  Preliminary data show activity of HuMax-CD20 that is similar to that of Rituxan in patients with CLL.3. The investment of GSK in this...
Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Analysis of: Lapatinib plus Capecitabine for HER2-Positive Advanced Breast Cancer (content.nejm.org)
1.  Lapatinib is a tyrosine kinase inhibitor of Her-22.  In a phase III clinical trial, patients with Her-2+ metastatic breast cancer who had progressed on regimens containing Herceptin, taxanes and anthracyclines and then received a combination of lapatinib and Xeloda had a significant improvement...

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