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All GLG News Analyses Filed Under: Oncology

Articles with lock require a GLG News subscription
Posted February 25, 2008
Implications for acceptance by FDA of Treanda for NHL
Analysis of: FDA Accepts TREANDA(R) New Drug Application for the Treatment of Relapsed Indolent Non-Hodgkin's Lymphoma | www.pipelinereview.com
Author: GLG Member Program Contributor
This acceptance implies that the drug has the potential for widespread use in relapsed low grade NHL . However,there are some provisos to the acceptance by a wide audience of physcians. The low toxicity rate and ease of delivery make this drug very attractive to use as do the high response rates...
Posted February 25, 2008
Genentech's future for Avastin depends on FDA
Analysis of: Genentech has billions at stake in FDA battle | sanfrancisco.bizjournals.com
Author: GLG Member Program Contributor
The brief article is providing an overview of Avastin's future for the treatment of breast cancer. Despite the 'waiting stage' to hear from FDA, physicians are already prescribing it on the ground of 'Compendia listing' status, which is based mainly on clinical trial data. Such an advance stage for...
Posted February 25, 2008
Potency not the critical parameter
Analysis of:  InNexus Biotechnology Announces Second Preclinical Candidate DXL702 (HER2/neu) Targeting Breast Cancer | www.pipelinereview.com
Author: GLG Member Program Contributor
Many competing antibodies to CD20 and Her2/neu.  Greater potency may not be important.  The therapeutic index might be the same since side effects are tied to the mechanism.  Cost of goods advantage due to lower dose will be minimal compared to generics by the time of launch.  Response...
Posted February 25, 2008
More than 1 mechanism and preclinical activity in hormone sensitive and resistant cancer
Analysis of: Hollis-Eden Pharmaceuticals Announces Filing of IND with APOPTONE(TM) in Hormone Sensitive Cancers to Commence Phase I/II Clinical Trial in Late-Stage Prostate Cancer | www.pipelinereview.com
Author: GLG Member Program Contributor
The novel steroid structures may have multiple mechanisms. In preclinical models, there is activity in both hormone receptor sensitive and insensitive prostate cancer.  It appears the first aim in trials will be in hormone sensitive patients (although they do say these will have been treated with...
Posted February 22, 2008
Comment on New drug for HRPC(Hormone Refractory Prostate Cancer)
Analysis of: Hollis-Eden Pharmaceuticals Announces Filing of IND with APOPTONE(TM) in Hormone Sensitive Cancers to Commence Phase I/II Clinical Trial in Late-Stage Prostate Cancer | www.pipelinereview.com
Author: GLG Member Program Contributor
1) This article is a bit confusing as in the beginning it refers to hormone sensitive disease,when in fact,later in the text,it is the HRPC(hormone refracory prostate cancer) cells that are targetted. 2)That being said,the mechanism of action and animal data look interesting and certainly worth pursuing...
Posted February 22, 2008
Treanda will expand Cephalon's Oncology presence with other drugs on the horizon
Analysis of: FDA Accepts TREANDA(R) New Drug Application for the Treatment of Relapsed Indolent Non-Hodgkin's Lymphoma | www.pipelinereview.com
Author: GLG Member Program Contributor
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...
Posted February 22, 2008
Avastin for Breast Cancer: Here Today Gone Tomorrow? No
Analysis of: Genentech has billions at stake in FDA battle | sanfrancisco.bizjournals.com
Author: Michael Grossbard, Professor of Clinical Medicine Columbia University College of Physicians and Surgeons
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...
Posted February 22, 2008
Previous FDA track records are against Genentech but don't disregard political activism!!!
Analysis of: Genentech has billions at stake in FDA battle | sanfrancisco.bizjournals.com
Author: GLG Member Program Contributor
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...
Posted February 22, 2008
Nexavar (Onyx & Bayer): down & out???
Analysis of: Onyx's Double Dose of Trouble | www.fool.com
Author: GLG Member Program Contributor
The Nexavar lung cancer trial was terminated by the data monitoring committee PLUS it caused increased deaths in the squamous cell subgroup. Future in lung cancer?? PLUS: recent info also has shown cardiac events in Nexavar making it a potential loser in the race for kidney cancer dollar.
Posted February 21, 2008
Treanda: A winner for Cephalon in Low grade non-Hodgkin's lymphoma (NHL) AND chronic lymphatic leukemia (CLL).
Analysis of: FDA Accepts TREANDA(R) New Drug Application for the Treatment of Relapsed Indolent Non-Hodgkin's Lymphoma | www.pipelinereview.com
Author: GLG Member Program Contributor
The FDA will be deciding on Treanda in CLL next month and with a litttle luck NHL in the fall of this year
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