Challenging Situations in the Management of Leukemias
By John M. Goldman, DM, FRCP, FRCPath, FMedSci, David Marin, MD, FRCP
The tyrosine kinase inhibitor (TKI) imatinib mesylate (Gleevec, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA) has transformed the treatment of patients with chronic myeloid leukemia (CML). Based on positive findings from the International Randomized Study of Interferon Versus STI571 (IRIS) trial,1 published in 2003, imatinib quickly replaced interferon-α as the standard of care. Imatinib has prolonged survival in newly diagnosed patients with chronic-phase (CP) CML; patients from the IRIS study have been followed now for 8 years.2 Their survival rate is 85% overall and 93% when only patients with CML-related deaths and those who have not received stem cell transplant are considered. The more potent BCR–ABL1 TKIs, dasatinib (Sprycel, Bristol-Myers Squibb Company, Princeton, NJ, USA) and nilotinib (Tasigna, Novartis Pharmaceuticals Corporation), were approved by the US Food and Drug Administration (FDA) in 2006 and 2007, respectively, as second-line agents in patients with imatinib resistance or intolerance, and in 2010 both agents received FDA approval for treatment of patients with newly diagnosed CML.
Managing chronic myeloid leukemia patients intolerant to tyrosine kinase inhibitor therapy
D J DeAngelo
Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA
The tyrosine kinase inhibitor (TKI) imatinib mesylate (Gleevec, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA) has transformed the treatment of patients with chronic myeloid leukemia (CML). Based on positive findings from the International Randomized Study of Interferon Versus STI571 (IRIS) trial,1 published in 2003, imatinib quickly replaced interferon-α as the standard of care. Imatinib has prolonged survival in newly diagnosed patients with chronic-phase (CP) CML; patients from the IRIS study have been followed now for 8 years.2 Their survival rate is 85% overall and 93% when only patients with CML-related deaths and those who have not received stem cell transplant are considered. The more potent BCR–ABL1 TKIs, dasatinib (Sprycel, Bristol-Myers Squibb Company, Princeton, NJ, USA) and nilotinib (Tasigna, Novartis Pharmaceuticals Corporation), were approved by the US Food and Drug Administration (FDA) in 2006 and 2007, respectively, as second-line agents in patients with imatinib resistance or intolerance, and in 2010 both agents received FDA approval for treatment of patients with newly diagnosed CML.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 24, 2012-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for accelerated review of ARIAD’s investigational BCR-ABL inhibitor, ponatinib, in patients with resistant or intolerant chronic myeloid leukemia (CML) or Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
The EPIC (Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia) trial is designed to provide definitive clinical data to support regulatory approval of ponatinib in treatment-naïve CML patients. The efficacy of ponatinib will be assessed in comparison to imatinib based on evaluation of the primary endpoint of major molecular response (MMR) rate at 12 months. ARIAD expects to complete patient enrollment in the trial by the end of 2013.
CML in pregnancy and childhood: Apperley J.
Jennifer Landis, Ning Yang, Ph.D., Andrew McDonald, Ph.D.
Reduced-Intensity Conditioning Versus Standard Conditioning Before Allogeneic Haemopoietic Cell Transplantation in Patients With Acute Myeloid Leukaemia in First Complete Remission: A Prospective, Open-Label Randomised Phase 3 Trial
Lancet Oncol. 2012 Sept 6;[Epub Ahead of Print], M Bornhauser, J Kienast, R Trenschel, et al
FDA Approves Bosutinib for Previously Treated CML
IMNG Medical Media. 2012 Sept 5, E Mechcatie
'Your Blood'
An independent supplement distributed by the Guardian on behalf of MediaPlanet who take sole responsibility for its contents.
In April 2013 the annual European Group for Blood and Marrow Transplantation (EBMT) conference will be held in London. As part of this conference, there is a dedicated Patient and Family Day on Saturday 6 April where the content is geared towards people who have had a bone marrow transplant – and of course their families.