© 2024 HSP News Service, L.L.C.
Abbott announced it has received 510k clearance from the FDA for a new in vitro diagnostic test to aid in determining the prognosis of patients with chronic lymphocytic leukemia (CLL). Abbott’s Vysis CLL FISH Probe Kit is the first FDA-cleared CLL test to aid in prognosis. The test detects genetic...
Certain preleukemic conditions and leukemia in high-risk patients have remained challenging to treat despite advances in hematology, according to Wendy Stock, MD, of the University of Chicago. But studies reported at the Best of ASCO® Annual Meeting ‘11 in Seattle show progress even in these ...
The FDA is warning the public that the leukemia drug dasatinib (Sprycel) may increase the risk of pulmonary arterial hypertension (PAH). Information about this risk has been added to the Warnings and Precautions section of the dasatinib drug label. In reported cases, patients developed PAH after...
Abbott announced today it has received 510(k) clearance from the FDA for a new in vitro diagnostic test to aid in determining the prognosis of patients with acute myeloid leukemia (AML) Abbott’s Vysis EGR1 FISH Probe Kit, the third Abbott fluorescence in situ hybridization (FISH) assay approved or...
The National Comprehensive Cancer Network (NCCN) 6th Annual Congress on Hematologic Malignancies, held recently in New York, included reviews of the management of hematologic diseases as well as discussions of outstanding issues in the field. The following is a synopsis of some of the important...
Cancer has nearly always been part of my life. When I was 6 years old, I was diagnosed with acute lymphoblastic leukemia. The doctors told my parents that unless I was treated immediately, I wouldn’t live longer than a month. Over the next 3 years, I underwent intensive courses of chemotherapy and...
The FDA has approved asparaginase Erwinia chrysanthemi (Erwinaze) to treat patients with acute lymphoblastic leukemia who have developed hypersensitivity to Escherichia coli–derived asparaginase (Elspar) and pegaspargase (Oncaspar). Acute lymphoblastic leukemia is the most commonly diagnosed...
In a randomized phase III trial among previously treated patients with relapsed or refractory chronic lymphocytic leukemia (CLL), the combination of alemtuzumab (Campath) plus fludarabine resulted in significant improvements in progression-free survival, complete response rate, and overall survival ...
Previous studies of gemtuzumab ozogamicin (Mylotarg) had variable results in acute myeloid leukemia (AML). Before trials reported at the 2011 ASH Annual Meeting, two major studies had compared chemotherapy with or without gemtuzumab in patients with AML, said Martin Tallman, MD, Chief of the...
A study presented at the Plenary Session of the 53rd Annual Meeting of the American Society of Hematology (ASH) breathes new life into an older drug for acute myeloid leukemia (AML) that is no longer available in the United States.1 Gemtuzumab ozogamicin (Mylotarg) appears to be a promising...
Gemtuzumab ozogamicin (Mylotarg) may have a second chance for regulatory acceptance, as studies presented at ASH 2011 demonstrated that gemtuzumab can be safely and effectively given by adjusting the dosing and treatment schedule. Gemtuzumab ozogamicin was approved for the treatment of acute...
A novel inhibitor of B-cell receptor signaling produced high rates of remission and was well tolerated in patients with chronic lymphocytic leukemia (CLL) who were refractory to at least two previous treatments, reported Susan O’Brien, MD, of The University of Texas MD Anderson Cancer Center,...
Susan O’Brien, MD, Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, Houston, has a special interest in novel developments in the treatment of acute lymphoblastic leukemia (ALL). At the 2011 ASH Annual Meeting, she discussed her picks of top newsmakers in ...
At the 2011 ASH Annual Meeting, Pierre Laneuville, MD, Director of Hematology at McGill University in Montreal, predicted that ponatinib may be “the drug that will replace them all” in the treatment of chronic myeloid leukemia. Dr. Laneuville explained his rationale, recalling that in the pivotal...
Initial results from the PACE (Ponatinib Ph+ ALL and CML Evaluation) trial added to accumulating evidence that the tyrosine kinase inhibitor ponatinib should soon be considered for front-line treatment of chronic myeloid leukemia (CML). “Robust responses were observed in all patient cohorts,” said...
Given the results of the BELA trial, with the problems of treatment side-effect management realized and seemingly resolved, Elias Jabbour, MD, Assistant Professor of Medicine at The University of Texas MD Anderson Cancer Center, Houston, assumes bosutinib will be approved in chronic myeloid...
The initial reports of the BELA trial (Bosutinib Efficacy and safety in chronic myeloid LeukemiA), presented at ASH 2010, were deflating. At 12-month follow-up, bosutinib failed to meet BELA’s primary endpoint. Things have since turned around, however, and results from the 24-month analysis...
Attendees at the 53rd Annual Meeting of the American Society of Hematology (ASH), held recently in in San Diego, were able to choose from a wide range of interesting and important sessions exploring hematologic malignancies. In addition to The ASCO Post’s regular news coverage from the meeting,...
Investigators in the Dutch-Belgian Hemato-Oncology Cooperative Group and the Swiss Group for Clinical Cancer Research Collaborative Group recently reported in the journal Blood that autologous peripheral blood stem cell transplantation significantly reduced relapse rate compared with intensive...
More than 3 decades ago, the first trials of autologous hematopoietic cell transplantation as consolidation therapy for acute myeloid leukemia (AML) in first remission were conducted. The initial results were inconclusive; most patients survived the procedure, but post-transplant relapse was common ...
Talon Therapeutics, Inc, announced the Oncologic Drugs Advisory Committee voted 7 yes, 4 no, and 2 abstain that evidence from clinical studies supports a favorable benefit-risk assessment for use of vincristine sulfate liposomes injection (Marqibo). The manufacturer is seeking an indication for the ...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication Erwinia chrysanthemi asparaginase (Erwinaze) was...
Throughout the course of medical history, we have witnessed innovations that have initially been met with skepticism but have later revolutionized our management of patients with specific disorders. The recent history of oncology drug development is full of instances where a drug that was...
The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology have become the most widely used guidelines in oncology practice. The Guidelines cover 97% of all patients with cancer and are continually updated by expert panels. The 2012 Guidelines include some completely...
A mutational analysis of 18 genes in 398 patients with acute myeloid leukemia (AML) found at least one somatic alteration in 97.3% of the patients and identified genetic predictors of outcome that improved risk stratification among patients with AML, independent of age, white-cell count, induction...
A study by the Children’s Oncology Group (COG) reported that 5-year survival for acute lymphoblastic leukemia (ALL) among children treated through COG clinical trials increased from 83.7% during the period 1990-1994 to 90.4% in the period 2000-2005. The improvements in survival were observed among...
Four decades ago, Kanti R. Rai, MD, was determined to figure out why some of his patients with chronic lymphocytic leukemia (CLL) died within 2 years after their diagnosis, while others lived for 20 or even 30 years. At the time, Dr. Rai was a young scientist doing research in leukemia at...
While failure of remission-induction therapy is rare in children and adolescents with acute lymphoblastic leukemia (ALL), when it does occur it is highly adverse and heterogeneous, according to a study in The New England Journal of Medicine. “Patients who have T-cell leukemia appear to have a...
Jay P. Patel, BS, and colleagues from Memorial Sloan-Kettering Cancer Center in New York recently performed mutational analysis of 18 genes in a subgroup of newly diagnosed acute myeloid leukemia (AML) patients who had been randomized to receive cytarabine plus high-dose or standard-dose...
With three available tyrosine kinase inhibitors for the treatment of chronic myeloid leukemia (CML), attention has turned from the ability to achieve a sustained response to the possibility of “curing” patients. Updates of pivotal trials presented at ASCO may help define the role of the tyrosine...
The third-generation tyrosine kinase inhibitor ponatinib showed robust efficacy in the 10-month follow-up of the phase II PACE trial (Ponatinib Ph+ALL and CML Evaluation), which is evaluating ponatinib in treatment-refractory chronic myeloid leukemia (CML)1 At the 2012 ASCO Annual Meeting, Jorge E. ...
Agents with novel mechanisms of action may strongly impact outcomes in chronic lymphocytic leukemia (CLL) and acute lymphocytic leukemia (ALL), if data from early-phase studies presented at this year’s ASCO Annual Meeting are any indication. There is a clear unmet need for more effective therapies...
The FDA has approved vincristine sulfate liposome injection (Marqibo) to treat adults with Philadelphia chromosome–negative acute lymphoblastic leukemia (ALL). Administered once a week, liposomal vincristine is approved for patients whose leukemia has relapsed two or more times, or whose leukemia...
In the News focuses on media reports that your patients may have questions about at their next visit. This continuing column will provide summaries of articles in the popular press that may prompt such questions, as well as comments from colleagues in the field. Computed tomography scans with...
The FDA has approved bosutinib (Bosulif) to treat chronic myelogenous leukemia (CML). The drug is intended for patients with chronic, accelerated, or blast phase Philadelphia chromosome–positive CML who are resistant to or who cannot tolerate other therapies, including imatinib (Gleevec). The...
As tyrosinse kinase inhibitors become increasingly effective in treating chronic myeloid leukemia (CML), major molecular responses (≥ 3-log reduction in BCR-ABL transcripts) are being achieved for a growing percentage of patients. “In the new era of tyrosinse kinase inhibitors, we are learning how...
Key studies on cancer epidemiology and prevention delivered both reassuring and not-so-reassuring findings on exposure to agents believed to be cancer-promoting. Kala Visvanathan, MD, MHS, of The Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine and School of Public Health, Baltimore,...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In September 4, 2012, bosutinib (Bosulif) was approved...
Bosutinib (Bosulif) is an oral dual Src/Abl kinase inhibitor that is active against many Bcr-Abl mutations associated with imatinib (Gleevec) resistance and that has reduced activity against nonspecific molecular targets associated with toxicities reported for other second-generation kinase...
Contradicting what some previous investigations have found, a study from The US Oncology Network found that adjuvant chemotherapy for breast cancer does not increase the risk of acute myeloid leukemia and myelodysplastic syndromes (AML/MDS), at least within the first 3 years of treatment.1 The...
Speakers at the National Comprehensive Cancer Network (NCCN) 7th Annual Congress on Hematologic Malignancies reviewed the current standard of care for various hematologic cancers and explored new concepts in treatment. Below are highlights from presentations on chronic myelogenous leukemia (CML),...
Chronic lymphocytic leukemia (CLL) is mainly a disease of the elderly, and the lack of a standard regimen for elderly patients has been a major challenge. The myelosuppressive regimens used to treat younger patients are not well tolerated by the elderly. However, some newer approaches currently...
Health-care professionals should report all serious adverse events suspected to be associated with the use of any medicine or device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178), by mailing the postage-paid...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In August 2012, vinCRIStine sulfate LIPOSOME injection...
Among patients aged 70 years and older with chronic lymphocytic leukemia (CLL), “front-line therapy with fludarabine does not improve outcomes” compared to chlorambucil (Leukeran), according to an analysis of patients enrolled in successive front-line Cancer and Leukemia Group B (CALGB) studies...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On October 26, 2012, the FDA granted accelerated...
Although still in preliminary testing with no phase III data, ibrutinib is poised to become an important new agent for patients with chronic lymphocytic leukemia (CLL). Two phase II trials reported at the 54th Annual Meeting of the American Society of Hematology (ASH) found that ibrutinib achieved...
In December, the FDA granted accelerated approval to ponatinib (Iclusig) for the treatment of adult patients with chronic-, accelerated-, or blast-phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy or Philadelphia chromosome–positive...
The pivotal phase II Ponatinib Ph+ ALL and CML Evaluation (PACE trial) found that 1 year of treatment with the novel investigational drug ponatinib achieved robust activity in heavily pretreated patients with chronic myeloid leukemia (CML) and Philadelphia chromosome–positive acute lymphoblastic...
James F. Holland, MD, began his journey into oncology when it was still a nascent discipline, working alongside groundbreaking pioneers in the field such as Drs. Emil “Tom” Frei and C. Gordon Zubrod. Dr. Holland recently shared a glimpse of his role in oncology’s formative years with The ASCO Post. ...