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GLG News by Multiple Myeloma Physicians

February 22, 2008
Previous FDA track records are against Genentech but don't disregard political activism!!!

By a GLG Expert Contributor

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...

February 22, 2008
Nexavar (Onyx & Bayer): down & out???

By a GLG Expert Contributor

Analysis of: Onyx's Double Dose of Trouble (www.fool.com)

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).

By a GLG Expert Contributor

Analysis of: FDA Accepts TREANDA(R) New Drug Application for the Treatment of Relapsed Indolent Non-Hodgkin's Lymphoma (www.pipelinereview.com)

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!

By a GLG Expert Contributor

Analysis of: Genentech has billions at stake in FDA battle (sanfrancisco.bizjournals.com)

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?

By a GLG Expert Contributor

Analysis of: Poniard Pharmaceuticals Announces Positive First-line Phase 1 Safety and Efficacy Data With Picoplatin in Metastatic Prostate Cancer Patients (www.pipelinereview.com)

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!

By a GLG Expert Contributor

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)

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

By a GLG Expert Contributor

Analysis of: Baxter Rival APP Steps In Quickly To Supply Heparin (online.wsj.com)

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.

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

February 19, 2008
More Data on Avastin Benefit in Breast Cancer But Still PFS and not OS Improvement

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...