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Donald Fleming

Dr. Donald Fleming MD

Division Head of Hematology and Oncology, DAVIS HEALTH SYSTEM INC

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GLG News by Dr. Donald Fleming MD, Division Head of Hematology and Oncology

Analyses are solely the work of the authors and have not been edited or endorsed by GLG.

Omapro will fill a CML void

November 14, 2009

US FDA accepts ChemGenex's Omapro NDA filing to treat CML, grants priority review status | www.pharmabiz.com

Patients with CML have a good prognosis when treated with TKI's An exception is the ones that develope a particular mutation known as T315IOnly SCT seems to be effective in this group of patients and maybe too morbid of therapy for many patients

Triple negative Breast Cancer Strategies

October 14, 2009

MediGene completes patient recruitment into EndoTAGTM-1 phase II breast cancer trial | www.pharmabiz.com

Triple negative Breast cancer has been a phenotype with little hope up until recentlyWhile advances in hormonal therapy and Her2 blocking agents has revolutionized ER/PR + and Her 2 positive breast cancer therapy, triple negative breast cancer pulls down the outcomes, with similar responses as for non small cell lung cancer

Farletuzumab (F) helps the ovarian cancer patients that do well, do well?

September 25, 2009

Farletuzumab Data Presented on Phase II Clinical Trial in First-Relapsed Ovarian Cancer Subjects | www.pipelinereview.com

F recently demonstrated a great majority of platinum sensitive patients respond when given in combination with a platinum based regimen in recurrent ovarian caPlatinum sensitive patients typically do well with platinum based intervention, but it's the platinum resistant ( denovo or delayed) that we have a problem with

Herceptin for Her2 + gastric cancer, If you can find one

September 25, 2009

Roche's Herceptin provides impressive survival benefit in HER2-positive advanced gastric cancer | www.pharmabiz.com

Herceptin recently reported in Phase II ASCo data to enhance chemo in Her 2 positive gastric cancer

REGORAFENIB joins a crowd of TKI's for RCC

September 25, 2009

Bayer's anti-cancer drug regorafenib shows stabilization or regression in 81% of kidney cancer patients | www.pharmabiz.com

RCC now has multiple TKI"S either approved or in development for txThe disease control rate seems to be a popular and effective endpoint to get drugs for RCC approved

Pay for performance Medicare "reform"

May 4, 2009

Medicare System Overhaul Proposed by Two Senators | www.nytimes.com

Medicare will reward based on outcome Medicare will pay for chronic illness acre based on outcome results Be careful about heading towards cancer care rationing

Alimta potential In India

February 27, 2009

Intas Biopharma to market Pemetrexed in India soon | www.pharmabiz.com

Alimta has been approved as upfront treatemnt of NSCLCA with platinum Alimta approved US as  single agent salvage treatment NSCLCa Market share IN US hsa been crowded out by other platinum combinations

tarceva adds to avastin but avastin doesn't add to tarceva?

February 17, 2009

OSI, Genentech Say Cancer Drug’s Benefits Ends Trial (Update2) | www.bloomberg.com

Beta lung demonstrated no benefit of adding avastin to tarceva as second line advanced lung cancer therapy Atals trial demonstrates adding tarceva to avastin after chemo in advanced lung cancer does benefit

More may or may not be better in colorectal cancer

February 6, 2009

Chemotherapy, Bevacizumab, and Cetuximab in Metastatic Colorectal Cancer | nejm.highwire.org

Recent trial such as PACE and CAIRO imply combo biologics are not helpful Is it likely this will hold true in future situations?

Plitidepsin ( Aplidin) helps in PTCL patients

January 19, 2009

PharmaMar announces the extension of Phase II trial with Aplidin(R) in Peripheral T-Cell Lymphoma after the excellent preliminary results | www.pipelinereview.com

New drug plitidepsin has anti tumor effects in PTCL patients PTCL is a relatively rare NHL form of NHL Plitidepsin has much more financial potential outside of NHL

Algeta completes comprehensive phase II clinical program with Alpharadin for treating bone metastases in patients with advanced prostate cancer

January 15, 2009

Algeta completes comprehensive phase II clinical program with Alpharadin for treating bone metastases in patients with advanced prostate cancer | www.pipelinereview.com

prostate cancer patients have  bone mets as a major problem Radioisotopic therapy has been designed to address the issue

Sublingual fentanyl for cancer related pain

January 5, 2009

Introducing Abstral(R). Innovative Drug Delivery Technology For Rapid Breakthrough Cancer Pain Management | www.medicalnewstoday.com

Always room for more pain medications/formulations for cancer patients The sublingual fentanyl approach is a highly desirable formulation due to rapid onset of action ie BTP control The concern is the faster they can be made to act, the more the abuse potential by non cancer patients

More is better with Acute Myelogenous Leukemia (AML)

December 22, 2008

Higher Chemo Drug Dose Prolongs Lives of Leukemia Patients | www.washingtonpost.com

Higher doses of conventional chemotherapy agent , improves outcome in AML A large population of  AML patients are elderly The "higher the dose of chemo, the better" concept still applies to some malignancies

It's always what's relative and seldom absolute

November 26, 2008

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

Satistics are usually used to reveal dramatic differences Patients often misinterpret relative differences for absolute ones patients are willing to do a lot more to get any benefit in cancer outcome

The rash and EGFR response can be helpful

November 19, 2008

Merck KGaA: Overall Survival in First-Line NSCLC Reaches 15 Months | www.drugs.com

Many studies support EGFR response correlates with rash Many attempts to actually increase the incidence of rash Most patients will use the EGFR treatments despite the rash

When being selective, targeted therapy will work

November 13, 2008

Tarceva successful as maintenance therapy | www.fiercebiotech.com

Saturn trial attempted to focus on EGFR reative patients Saturn was positive as a maintenance therapy, while concurrent was not

The TKI's are building on their success

October 28, 2008

Phase II Trial of Sorafenib in Advanced Thyroid Cancer | jco.ascopubs.org

TKI's have been establihed in a small number of refractory solid cancers With slow migration to other venues, we are seeing new applications

Vaccine for prostate cancer fails

October 28, 2008

Cell Genesys Announces Termination of VITAL-1 Phase 3 Trial of GVAX Immunotherapy for Prostate Cancer | pharmalive.com

Recent Cell Genesys vaccine trial for prostate cancer fails The trial not only shows lack of efficacy, but possible harm from the vaccine arm of the trial

Hitting the target may reduce the use of targeted cancer drugs or not

October 27, 2008

Targeting EGFR in Colorectal Cancer | content.nejm.org

We are facing an ever increasing expense of treating cancver The so called targeted drugs are the big price items The recent discovery of theses drugs have sometimes been out of order with understanding their activity

The vaccine approach to cancer has yet to succeed

October 24, 2008

Cell Genesys Announces Termination of VITAL-1 Phase 3 Trial of GVAX Immunotherapy for Prostate Cancer | pharmalive.com

Be cautious of vaccine approaches to cancer No cancer has had success with the use of vaccine therapy We are far from figuring out the reason for failure of vaccines to treat cancer

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