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GLG News by Oncologists who Treat Hematologic Malignancies (US)

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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 Expert 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...
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 Expert 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...
February 22, 2008
Nexavar (Onyx & Bayer): down & out???
Analysis of: Onyx's Double Dose of Trouble | www.fool.com
Author: GLG Expert 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.
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 Expert Contributor
The FDA will be deciding on Treanda in CLL next month and with a litttle luck NHL in the fall of this year
February 21, 2008
Avastin (Genentech): Approval in breast cancer? It would be the correct thing to do!
Analysis of: Genentech has billions at stake in FDA battle | sanfrancisco.bizjournals.com
Author: GLG Expert Contributor
Genentech has it's fingers crossed Re: approval or rejection of Avastin in breast cancer. If rejected it will lose it's compendia listing also adversely effecting insurance reimbursement.
February 20, 2008
Picoplatin (Poniard) in Metastatic Prostate Cancer: Why not?
Analysis of: Poniard Pharmaceuticals Announces Positive First-line Phase 1 Safety and Efficacy Data With Picoplatin in Metastatic Prostate Cancer Patients | www.pipelinereview.com
Author: GLG Expert Contributor
Picoplatin + Taxotere (Sanofi) appears in a Phase I trial, to be better than Taxotere alone in reducing PSA levels in metastatic prostate cancer (MPCA.)      (Comparing historical, not head to head data)
February 20, 2008
GVAX (Cell Genesys) In Metastatic Prostate Carcinoma (MPCA). I'm Impressed So Far!
Analysis of: Cell Genesys Reports Association Between Immune Response and Patient Survival in Phase 2 Trial of GVAX Immunotherapy for Prostate Cancer | www.pipelinereview.com
Author: GLG Expert Contributor
Immunologic response translated into improved survivals in 1/2 of the trial subjects!
February 19, 2008
While Baxter and APP "fiddle" GSK's Lovenox should jump into the void
Analysis of: Baxter Rival APP Steps In Quickly To Supply Heparin | online.wsj.com
Author: GLG Expert Contributor
APP wants to jump into the void created by Baxter's "allergic" problems related to Chinese suppliers. BUT APP appears to also obtain some of it's product from China and with FDA's scrutiny I would not bet on continued supplies.
February 18, 2008
Sutent's " Cardiac Worries" grow: Nexavar and Torisel to benefit
Analysis of: Kidney Cancer Drug Linked to Higher Rate of Heart Problems | www.washingtonpost.com
Author: GLG Expert Contributor
Yet another study, although small, report 15 5 incidence of cardiac abnormalities in patients receiving Pfizer's Sutent. The abnormalities persist and are serious in patients with previous history of cardiac disease. Sutent is an efficacious drug, but it has alternative options ( Nexavar and Torisel...
February 18, 2008
Sutent (Pfizer) causes heart failure?? Advantage Nexavar (Bayer/Onyx) and Torisel (Wyeth)
Analysis of: Kidney Cancer Drug Linked to Higher Rate of Heart Problems | www.washingtonpost.com
Author: GLG Expert Contributor
Sutent is associated with cardiac dysfunction!?

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