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

Analysis of: Antisoma starts phase I clinical trial of AS1409 in renal cancer and melanoma (www.pipelinereview.com)
Antisoma's AS 1409 has just entered a clinical phase I trial for patients with advanced melanoma and renal cancer. While efficacy results are years ago, this "immunotherapy" will be competing with many approved targeted agents in renal cancer ( Sutent, Nexavar, Torisel) and with many other immunotherapeutic...
Analysis of: Novartis Late-State Cancer Trial Is Stopped Early After Meeting Goal (online.wsj.com)
the "Record" trial showed that Novatis' m-Tor inhibitor, everolimus improved progression free survival as compared to placebo in patients with advanced renal cancer who failed several other therapies including Avastin ( Genentech), Nexavar ( Bayer) and/or Sutent ( Pfizer). With The field of targeted...
Analysis of: Vaccinating Boys for Girls’ Sake? (www.nytimes.com)
Merck's HPV vaccine, Gardasil is expected to be approved for boys to extend "herd immunity" and offer more prevention to girls from cervical cancer. This " altruistic" goal comes with benefits for boys: eradication of 90 % of genital warts cases, and possible long term prevention of anal , penile, and...
Analysis of: Genentech Clears Hurdle On Cancer Drug Avastin (online.wsj.com)
As expected, FDA gave accelerated approval for Genetech's Avastin in metastatic breast cancer, thus requiring Genentech to do further studies to show survival benefit and confirm the PFS survival. This decision will "officially" introduces Avastin to breast cancer market, where use has been already...
Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Analysis of: FDA Accepts TREANDA(R) New Drug Application for the Treatment of Relapsed Indolent Non-Hodgkin's Lymphoma (www.pipelinereview.com)
Treanda (Bendamustine) combines the activity of a purine analog and alkylating agent, two of the most potent cytotoxic classes in therapy of indolent NHL.  Older data from Europe as well as more recent clinical trials have confirmed the excellent activity of Treanda in indolent NHL and CLL. ...
Analysis of: FDA Accepts TREANDA(R) New Drug Application for the Treatment of Relapsed Indolent Non-Hodgkin's Lymphoma (www.pipelinereview.com)
Cephalon's Treanda have shown efficacy in relapsed/refractory indolent NHL and also in CLL, and is expected to get FDA approval for both indications. Cephalon currently has FDA approval for Trisenox for relapsed APL ( a less common form of AML) and is developing Lasteurinib for FLT-3 positive...
Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Analysis of: Genentech has billions at stake in FDA battle (sanfrancisco.bizjournals.com)
Avastin is often used for the treatment of stage IV breast cancer.  Based on compendia listing and published data, Avastin prolongs DFS when given in combination with a Taxane as initial breast cancer therapy.  However, this market share ay be jeopardized if the FDA fails to approve Avastin...
Analysis of: Genentech has billions at stake in FDA battle (sanfrancisco.bizjournals.com)
Historically , FDA follows the recommendations of its advisory committee, in this case to reject approval of Avastin. This is an election year but breast cancer patients and their families are strong activists, not to mention Genetech's mighty connections , so approval with restrictions , especially...
Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
February 19, 2008
Strike One for Sutent
Analysis of: Kidney Cancer Drug Linked to Higher Rate of Heart Problems (www.washingtonpost.com)
Several agents have recently received FDA approval for the treatment of renal cell carcinoma including Sutent, Nexavar and Torisel.  The recent study describes a 15% rate of cardiovascular toxicities in patients  receiving Sutent including heart failure.  Y+This is a higher rate than...
Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Analysis of: Genentech’s Avastin Slows Spread Of Breast Cancer (www.pharmalot.com)
Avastin faces a substantial hurdle when it goes before the FDA for approval in first line breast cancer therapy.  There has been much debate over the progression free survival benefit (5.5 months) but no overall survival benefit for this agent.  The newly reported European data on Avastin...

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