Dr. Michael Grossbard MD

GLG News by Dr. Michael Grossbard MD, Professor of Clinical Medicine

GLG News is now G+ Insights

G+ is a community for professionals, academics and entrepreneurs to connect through online discussions and in-person meetings. You will continue to see G+ Insights (formerly GLG News) here as well as on the G+ website, where you can share and discuss the G+ Insights you read.

Avastin Raises Risk of Clots: New News?

December 1, 2008

Analysis of:Scientists recommend 'black box' for Avastin | www.fiercepharma.com

In pooled data from 8000 patients across 15 studies, the risk of blood clots was increased by 12% in patients receiving Avastin.

Amgen Rewords Label: Less Use of Procrit

August 29, 2008

Analysis of:Amgen Told to Reword Drug Label | www.nytimes.com

The FDA required Amgen to revise the label for Procrit and Aranesp so that these agents are not used until a patient's hemoglobin drops below 10 or in the setting of potentially curative therapy.

Transparency in Healthcare: How to Assess?

August 29, 2008

Analysis of:Transparency in Healthcare | www.hospitalimpact.org

The author argues that transparency in healthcare will be an important step forward for the consumer.

Avastin: Worth the Cost?

August 29, 2008

Analysis of:Costly Cancer Drug Offers Hope, but Also a Dilemma | www.nytimes.com

Avastin improves survival in colon cancer and lung cancer and improves progression free survival in breast cancer- clinically meaningful outcomes.  Yet these gains are of relatively short duration and the cost of Avastin is significant- 50,000 to 100,000 dollars per year.

NICE States Novel Therapies for Renal Cell Cancer Too Costly

August 28, 2008

Analysis of:UK Says Kidney Cancer Drugs Are Too Pricey | www.pharmalot.com

NICE has stated that the cost of several novel agents for the treatment of renal cell cancer including Sutent, Torisel, Avastin, and Nexavar exceeds the benefit when assessed by quality adjusted life years (QALY) gained from the therapies.

One Drug Many Uses: Prove It

July 7, 2008

Analysis of:One drug, many uses. Good idea? | www.indystar.com

Lilly has devoted substantial energy/expense in developing Cymbalta for many indications.  Is this at the expense of developing novel agents? 

Can China Make Generics Better than They Make Toys

July 7, 2008

Analysis of:China Muscles In On The Generics Industry | www.pharmalot.com

Several Chinese companies are set to enter the generic drug market ove the next year.  If these agents are demonstrated to be safe, they could have a large impact on the generic drug industry.

Avastin Effecitve in Lung and Breast Cancer But is it Cost Effective?

July 7, 2008

Analysis of:Roche decision denies cancer drug to Britons | www.ft.com

Roche has elected not to provide information on the cost effectiveness and clinical effectiveness of Avastin in breast cancer to the medicine advisory board of the British government.  As such, the drug will not be able for first line treatment of these diseases in Britain.

New Agents Needed for Therapy of Neuropathy in Cancer Patients- Is AL-309 the Agent?

May 19, 2008

Analysis of:Allon data demonstrate potential of AL-309 as a new neuropathy treatment | www.pipelinereview.com

Cancer patients frequently develop neuropathy as a results of chemotherapy agents including oxaliplatin, paclitaxel, vinca alkaloids, and Velcade.  Because many such patients have extended survival or receive treatment with curative intent, the resultant neuropathy can limit quality of life significantly.  New agents are much needed for the prevention and treatment of neuropathy.   

Proteosome Inhibition with Carfilzomib is Promising Therapeutic Avenue

May 19, 2008

Analysis of:Proteolix Initiates Phase 2 Clinical Trial of Carfilzomib in Patients with Relapsed Solid Tumors | www.pipelinereview.com

Carfilzomib is a nvelo prteosome inhibitor.  Bortezomib, the only proteosome inhibitor that is currently FDA approve, has shown significant activity in myeloma and mantle cell NHL and is being tested in other hematologic malignancies.  If Carfilzomib has improved toxicty and greater efficacy than Bortezomib, it may have a significant role in cancer therapy.

Ricin Vaccine Market Relies on Threat of Terror

May 5, 2008

Analysis of:DOR BioPharma Initiates Non-Human Primate Efficacy Studies of RiVaxTM, Its Vaccine Against Ricin Toxin | www.pipelinereview.com

Ricin is an extraordinarily potent toxin that is fatal because of its ability to inhibit protein synthesis and rapidly cause multisystem failure.  Because ricin can be prepared from castro beans, it has the potential to be used in terrorist attacks.  The present vaccine has the potential to neutralize the toxicity of ricin.

Too Early to Draw Conclusions Yet on Vargatef

May 5, 2008

Analysis of:Data suggests promising overall survival and progression-free survival with Vargatef(TM) (BIBF 1120) | www.pipelinereview.com

Vargatef is a novel angiokinase inhibitor that blocks VEGF, PDGR and FGF receptors.  The current phase II study in patients with non small cell lung cancer shows that this oral agent can be given safely.  It is far too early to draw conclusions regarding efficacy.

Immunoconjugates Are Better in Theory Than Practice

March 31, 2008

Analysis of:Immunomedics Develops New Immunoconjugates for Targeted Chemotherapy of Pancreatic and Other Cancers | www.pipelinereview.com

Immunomedics has developed three new immunoconjugates between monoclonal antibodies and SN-38 i an effort to target colon, pancreas and lung cancer.  Preclinical data are effective in a metastatic colon cancer model but there are no clinical data.

Treanda Likely Big Winner in Indolent NHL

February 25, 2008

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.  Both of these diseases are essentially incurable and patients will receive many treatments over the course of their disease.  Treanda's efficacy and toxicity profile as well as the ability to combine this agent effectively with Rituxan will make this a popular second line therapy for patients with indolent NHL. 

Avastin for Breast Cancer: Here Today Gone Tomorrow? No

February 22, 2008

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 for breast cancer use later this month. 

Strike One for Sutent

February 19, 2008

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 previously reported and, if validated in further studies, will have an impact on the use of Sutent in renal cell carcinoma as well as an impact on its development for use in other cancers.  

More Data on Avastin Benefit in Breast Cancer But Still PFS and not OS Improvement

February 19, 2008

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 and Taxotere appear to confirm the benefit of Avastin on PFS in patients with breast cancer. 

Can Hematiide Replace Aranesp/Procrit for Chemotherapy Induced Anemia?

January 30, 2008

Analysis of:Takeda Doses First Patient in A U.S. Phase 1 Study of Hematide(TM) to Treat Chemotherapy Induced Anemia | www.pipelinereview.com

Anemia represents a common problem in patients treated with chemotherapy.  Although Aranesp and Procrit represented frequently used therapies for the treatment of chemotherapy induced anemia, the recent warnings regarding potential toxicities of these agents limit their use by many physicians.  Hematide would represent a potential alternative therapy for the management of chemotherapy induced anemia, perhaps with an improved toxicity profile over the agents already available.

Neuropathic Pain: Large Market- Few Good Options

January 30, 2008

Analysis of:Pipeline Insight: Neuropathic Pain - Emerging drugs fail to capitalize in lucrative market | www.pipelinereview.com

As I medical oncologist, I frequently deal with neuropathic pain caused either directly by tumors or for complications of cancer therapy.  this is a frequent complaint that impairs quality of life for cancer patients.  Current options for treatment all provides suboptimal efficacy and there is a large market potential if new therapies can be developed even with only a modest increase in efficacy.

More Support for Rituxan in CLL

January 30, 2008

Analysis of:MabThera increases the time patients with the most common form of adult leukaemia live without their cancer progressing | www.pipelinereview.com

Rituximab is an anti-CD 20 monoclonal antibody with activity in many diseases including non-Hodgkin's lymphoma and chronic lymphocytic leukemia.  The current phase 3 trial provides further support for the use of rituximab in patients with CLL and is the first study to definitively show an improvement in progression free survival for patients who are treated with this agent.

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