Blood Journal-Long-term prognostic significance of early molecular response to imatinib
Long-term prognostic significance of early molecular response to imatinib in newly diagnosed chronic myeloid leukemia: an analysis from the international randomized study of interferon versus STI571 (IRIS). an analysis from the international randomized study of interferon versus STI571 (IRIS)
Timothy P. Hughes1,*, Andreas Hochhaus2, Susan Branford3,Martin C. Müller4, Jaspal S. Kaeda5, Letizia Foroni6,Brian J. Druker7, François Guilhot8, Richard A. Larson9,Stephen G. O'Brien10, Marc S. Rudoltz11, Manisha Mone11,Elisabeth Wehrle12, Vijay Modur13, John M. Goldman6 andJerald P. Radich14 ...read more
Haematology Times- EHA role of Patient Advocacy
Patient advocacy in clinical trials- EHA Congress, June 10-13th, 2010, Barcelona—Though recent developments aim to improve the clinical trial process, a group of experts says much more work is necessary.
At the 15th Congress of the European Hematology Association, three speakers discussed the patient-specific challenges of the clinical trial process and offered potential solutions to overcome them. The speakers attacked the issue from all sides, as each represented a different perspective: that of the clinician, the pharmaceutical industry, and the patient. ...read more
Discovery suggests possible treatment strategy for aggressive leukemias
Researchers at Duke University Medical Center have identified a mechanism that could explain how patients move into the worst phase of chronic myelogenous leukemia (CML).
The work appears in Nature online on July 18. Their findings implicate a protein called Mushashi that prevents cells from maturing, creating a large population of immature cells, which is one of the hallmarks of CML. ...read more
Tasigna Beats Sprycel to First-Line CML Punch
The Pink Sheet Daily, 2010 Jul 5. J Merrill
Now that Novartis' Tasigna (nilotinib) has been approved by FDA for the treatment of first-line chronic myeloid leukemia, the race has officially begun for two second-generation BCR-ABL kinase inhibitors to supplant the venerable market-leader, Novartis' Gleevec (imatinib).
The other competitor expected soon to be vying for a piece of the first-line market is Bristol-Myers Squibb with its Sprycel (dasatinib). That drug, approved since 2006 for second-line CML, has not yet been cleared for first line but did demonstrate superiority over Gleevec in a Phase III clinical trial. Bristol has recently filed an sNDA seeking FDA approval for the indication. ...read more
Bosutinib Induces High Response Rates in Imatinib-Resistant, -Intolerant Patients
Bosutinib Induces High Response Rates in Imatinib-Resistant, -Intolerant Patients
Elsevier Global Medical News. 2010 Jun 21, N Osterweil
CHICAGO (EGMN) - Bosutinib shows clinical efficacy in imatinib-resistant or -intolerant patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase, with complete cytogenetic response rates of 50% in a multinational study, investigators reported.
At 24 months of follow-up, 77% of imatinib (Gleevec)-resistant patients and 86% of imatinib-intolerant patients who were treated with the investigational drug were alive without evidence of disease progression, and median progression-free survival has not yet been reached in either group, according to Dr. Jorge E. Cortes of the University of Texas M.D. Anderson Cancer Center in Houston.....more
www.oncologystat.com/news/Bosutinib_Induces_High_Response_Rates_in_Imati...
ASCO 2010- Abstracts from the yearly meeting of the American Society of Clinical Oncology
Imatinib 800 mg Associated With Faster MMR vs Imatinib 400 mg or Imatinib 400 mg Plus Interferon in Previously Untreated Chronic-Phase CML. June 11, 2010- German CML Study IV: randomized, treatment optimization trial......
http://www.clinicaloptions.com/Oncology/Conference%20Coverage/Clin%20Onc%20June%202010/ ...read more
Welcome to CMLSupport.org.uk - please sign our petition!
Sandy Craine, a CML patient and director of The CML Support Group said: ”Patients are angry, frightened and very frustrated by this inhumane provisional recommendation by the NICE appraisal committee- a recommendation that seems to us to have much more to do with cost cutting than with a rational appraisal of two highly effective and innovative therapies. If the recommendation is upheld, and NHS funding of these therapies is refused in cases of imatinib intolerance, it will undoubtedly cost lives. It is a shocking prospect that UK citizens, who prove to be intolerant to standard dose imatinib (Glivec) will be denied access to such effective and life-saving alternatives. Clinicians will find themselves unable to treat their patients within internationally agreed expert recommendations outlined by the European Leukaemia Network, with the knowledge that clinicians in Germany, France, the Netherlands and other EU countries, are able to offer their patients the very best therapeutic options available.
Making Expanded Access Programs Work For –Not Against– Your Trial Drug
The Pink Sheet Daily. 2010 Jun 7, E Hayes
Providing an investigational drug outside of a controlled trial carries inherent development risks, but it can also be a win-win proposition for patients and sponsors when managed well, veterans of "expanded access" programs say.
According to the FDA's broad definition, "expanded access" could mean a one-time supply of a drug to a particular patient, or a program that serves tens of thousands of patients. Globally, the terms "early access" and "compassionate use" are also used for similar programs. ...read more
New England Journal - Editorial
Even Better Kinase Inhibitors for Chronic Myeloid Leukaemia: Charles L. Sawyers, M.D
The clinical success of imatinib in patients with chronic myeloid leukemia (CML), which was first reported 9 years ago,1 catalyzed a systemwide shift in the development of cancer drugs to include molecularly targeted therapies. According to one recent estimate, approximately 200 such drugs are now in the clinical-development pipeline. First approved for interferon-resistant CML, imatinib quickly became the standard of care in patients with newly diagnosed CML on the basis of the drug's remarkable efficacy (complete cytogenetic remissions in some 70% of patients) with minimal toxic effects when used as initial therapy.2 Success of that magnitude is rare in oncology.
But imatinib was the first drug of its kind — an early foray into the world of kinase inhibition when the properties of the ideal candidate drug were completely unknown. By today's standards, imatinib has relatively low potency and inhibits its target at micromolar rather than nanomolar concentrations. In addition, imatinib is susceptible to resistance through a large number of different mutations in the BCR-ABL target as a consequence of the way it binds the BCR-ABL kinase domain, an unforeseen issue at the time of its discovery.
read more....http://content.nejm.org/cgi/content/full/NEJMe1004430?query=OF
Impact of JAK2V617F-mutation status, allele burden and clearance after allogeneic stem cell transplantation for myelofibrosis
Impact of JAK2V617F-mutation status, allele burden and clearance after allogeneic stem cell transplantation for myelofibrosis
Haefaa Alchalby1, Anita Badbaran1, Tatjana Zabelina1, Guido Kobbe2, Joachim Hahn3, Daniel Wolff3, Martin Bornhäuser4, Christian Thiede4, Herrad Baurmann5, Wolfgang Bethge6, York Hildebrandt1, Ulrike Bacher1, Boris Fehse1, Axel R. Zander1 and Nicolaus Kröger1,*
1 Dept. of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; 2 Dept. of Hematology/Oncology, University Hospital Dusseldorf, Dusseldorf, Germany; 3 Dept. of Hematology/Oncology, University Hospital Regensburg, Regensburg, Germany; 4 Dept. of Hematology/Oncology, University Hospital Dresden, Dresden, Germany; 5 Dept. of Stem Cell Transplantation, DKD Clinic, Wiesbaden, Germany; 6 Dept. of Hematology and Oncology, University Hospital Tubingen, Tubingen, Germany
* Corresponding author; email: nkroeger@uke.uni-hamburg.de
Abstract: read more....
