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Novel agents such as ibrutinib (Imbruvica), idelalisib (Zydelig), and venetoclax (Venclexta) have transformed the treatment of chronic lymphocytic leukemia (CLL) and are increasingly used to treat the disease. The optimal sequencing of these agents is not clear in relapsed or refractory disease,...
As reported in the journal Blood by Flinn et al, the phase III DUO trial has shown significantly prolonged progression-free survival with the phosphoinositide 3-kinase (PI3K)-δ,-γ inhibitor duvelisib (Copiktra) vs ofatumumab (Arzerra) in patients with relapsed or refractory chronic...
As reported in the Journal of Clinical Oncology by Pigneux et al, a French phase III trial (LAM-SA 2007 FILO) has shown an overall survival benefit with the addition of lomustine to conventional chemotherapy in older patients with acute myeloid leukemia (AML) without unfavorable cytogenetics....
ON SEPTEMBER 24, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to duvelisib (Copiktra) for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. Duvelisib also received accelerated...
Despite survival gains for children diagnosed with acute lymphoblastic leukemia (ALL), adolescents and young adults (AYAs)—those between the ages of 15 and 39—diagnosed with the disease have seen only modest improvements in survival. A study by Wolfson et al in Cancer Epidemiology,...
The U.S. Food and Drug Administration (FDA) recently permitted marketing of the ClonoSEQ assay, a next-generation sequencing–based test for minimal residual disease in patients with B-cell acute lymphoblastic leukemia (ALL) or multiple myeloma. “At the FDA, we’re continuing to...
The Beat AML Master Clinical Trial seeks to change the treatment paradigm and outcomes in acute myeloid leukemia (AML) by personalizing therapy and ultimately facilitating the approval of novel targeted agents. Co-investigator William Blum, MD, of the Winship Cancer Institute at the Emory...
Chronic myeloid leukemia (CML) is a poster child for the success of molecularly targeted therapy, with some patients appearing to be “cured” of their disease and others living for a long time after treatment with a tyrosine kinase inhibitor targeting the BCR-ABL1 protein. However, there are still...
As reported by Lin et al in the Journal of Clinical Oncology, cost-effectiveness modeling of treatment with the anti-CD19 chimeric antigen receptor T-cell therapy tisagenlecleucel (Kymriah) in relapsed or refractory pediatric B-cell acute lymphoblastic leukemia (ALL) showed that price reduction...
Jerald P. Radich, MD, of the Fred Hutchinson Cancer Research Center, discusses the best strategies for sequencing tyrosine kinase inhibitor therapy for chronic myeloid leukemia and treatment-free remission.
On September 24, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to duvelisib (Copiktra) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. In addition, duvelisib...
ON SEPTEMBER 13, 2018, the U.S. Food and Drug Administration (FDA) approved moxetumomab pasudotox-tdfk (Lumoxiti) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies,...
In a retrospective registry study reported in JAMA Oncology, Mohamad Mohty, MD, PhD, of Hôpital Saint Antoine, Université Pierre et Marie Curie, and colleagues found no overall survival difference with second allogeneic hematopoietic cell transplantation (HCT) vs donor lymphocyte infusion (DLI) in ...
Investigators have unraveled the origins and identified mutations associated with mixed-phenotype acute leukemia. The study, published by Alexander et al in Nature, potentially lays the foundation for more effective treatment of patients with this high-risk cancer. Mixed-phenotype acute...
A pair of new studies from researchers at the Abramson Cancer Center of the University of Pennsylvania are shedding light on why patients with advanced chronic lymphocytic leukemia (CLL) respond or do not respond to chimeric antigen receptor (CAR) T-cell therapy. Although CAR T-cell therapy is...
Moxetumomab pasudotox produced deep and durable responses in a heavily pretreated population of patients with hairy cell leukemia, with the ability to eradicate minimal residual disease. The drug showed a favorable safety profile with less bone marrow suppression than with purine nucleoside analog...
In elderly patients with untreated acute myeloid leukemia (AML), venetoclax (Venclexta), given at a 400-mg dose, with an azacitidine backbone led to durable responses with a tolerable safety profile, according to data from a phase Ib dose-escalation and -expansion study. Response rates were high...
In a population-based cohort study reported in The Lancet Oncology, Hargreave et al found that recent maternal use of hormonal contraception was associated with increased risk of childhood nonlymphoid leukemia. Study Details The study involved data from a nationwide cohort of...
A high incidence of clinically diagnosed infections in the first year of life among children who later developed acute lymphoblastic leukemia (ALL) has led researchers to propose that children with ALL are born with a dysregulated immune function, resulting in a more vigorous reaction to infections ...
The U.S. Food and Drug Administration (FDA) today approved moxetumomab pasudotox-tdfk (Lumoxiti) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with...
Case studies have reported a high prevalence of methotrexate subacute neurotoxicity among Hispanic adolescents with acute lymphoblastic leukemia (ALL), suggesting sensitivity to methotrexate therapy may differ by race and ethnicity. Now, a prospective study in pediatric patients with ALL has found...
IN A STUDY of National Cancer Database data reported in Blood Advances, Vijaya Raj Bhatt, MD, of the University of Nebraska Medical Center, and colleagues found that 25% of patients with newly diagnosed acute myeloid leukemia (AML) did not receive initial chemotherapy, despite evidence that...
In an interim analysis of a European trial reported in The Lancet Oncology, Francois-Xavier Mahon, MD, of Institut Bergonié, Bordeaux, and colleagues found that discontinuation of tyrosine kinase inhibitor therapy in patients with chronic myeloid leukemia (CML) with deep molecular response was...
As reported by Winter et al in the Journal of Clinical Oncology, findings in the Children’s Oncology Group (COG) AALL0434 trial indicate improved outcomes with a COG methotrexate intensification regimen vs a high-dose methotrexate intensification regimen in children and young adults with...
The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for dasatinib in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia...
The European Commission (EC) recently approved the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) in the European Union (EU) for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is...
EARLY IN 2018, blinatumomab (Blincyto) was granted accelerated approval for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease ≥ 0.1%.1,2 Supporting Efficacy Data APPROVAL WAS...
ON JULY 20, 2018, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test.1,2 The FDA...
The U.S. Food and Drug Administration (FDA) has granted ASLAN003 Orphan Drug designation as a treatment for acute myeloid leukemia (AML). ASLAN003 is an orally active, potent inhibitor of human dihydroorotate dehydrogenase (DHODH) that has the potential to be a first-in-class drug in AML. The FDA...
In a German phase II trial reported in The Lancet Oncology, Cramer et al found promising response rates with bendamustine followed by obinutuzumab (Gazyva) plus venetoclax (Venclexta) in both treatment-naive and relapsed/refractory chronic lymphocytic leukemia (CLL). In the trial, patients with an ...
Almost 1 year after the U.S. Food and Drug Administration (FDA) approval of chimeric antigen receptor (CAR) T-cell therapy for children with acute lymphoblastic leukemia (ALL), researchers at The University of Texas MD Anderson Cancer Center and the Pediatric Acute Lung Injury and...
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to quizartinib, an investigational FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). Breakthrough Therapy designation is designed to...
Results were recently announced from the ASTRAL-1 study evaluating the efficacy and safety of guadecitabine in adults with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive induction chemotherapy. The study did not meet its co-primary endpoints: complete...
In an analysis of Asian trials reported in the Journal of Clinical Oncology, Yeoh et al found evidence that treatment intensification improved outcomes in childhood B-cell acute lymphoblastic leukemia (B-ALL) with IKZF1 deletion (del). The analysis compared outcomes in the Malaysia-Singapore ALL...
On July 20, 2018, the U.S. Food and Drug Administration approved ivosidenib (Tibsovo) for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. Approval was based on an open-label, single-arm, multicenter...
In a pivotal phase III trial reported in the Journal of Clinical Oncology, Lancet et al found that cytarabine and daunorubicin liposome (CPX-351, Vyxeos) significantly improved overall survival vs standard cytarabine plus daunorubicin (7+3 regimen) in older patients with newly diagnosed secondary...
Susan M. O’Brien, MD, of the University of California, Irvine, discusses three oral agents for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma, and the use of chemotherapy for the disease.
In a retrospective registry study reported in JAMA Oncology, Kharfan-Dabaja et al found no overall survival difference with second allogeneic hematopoietic cell transplantation (HCT) vs donor lymphocyte infusion (DLI) in patients with acute myeloid leukemia (AML) relapse. The study involved 418...
Today, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (isocitrate dehydrogenase-1 [IDH1]...
The National Comprehensive Cancer Network® (NCCN®) has recently released The NCCN Guidelines for Patients with Acute Myeloid Leukemia (AML), which includes resources for better-informed medical decision-making. The NCCN Guidelines for Patients with AML is endorsed by the Aplastic Anemia and MDS...
SUSAN O’BRIEN, MD, Associate Director for Clinical Science, Chao Family Comprehensive Cancer Center, University of California Irvine Health, told The ASCO Post that the pairing of ibrutinib (Imbruvica) and venetoclax (Venclexta) “is clearly a very powerful combination.” The next question, she...
A REGIMEN COMBINING ibrutinib (Imbruvica) and venetoclax (Venclexta) in previously untreated patients with chronic lymphocytic leukemia (CLL) greatly reduced the risk of venetoclax-associated tumor-lysis syndrome and led to promising rates of undetectable minimal residual disease (MRD) in the phase ...
The U.S. Food and Drug Administration (FDA) recently accepted a new drug application and granted Priority Review designation for glasdegib, an investigational oral smoothened inhibitor being evaluated for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) in...
As reported in The New England Journal of Medicine by Shannon L. Maude, MD, PhD, of Perelman School of Medicine, University of Pennsylvania, Philadelphia, and colleagues, the phase II ELIANA trial has shown that the anti-CD19 chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) ...
In an analysis of the Children’s Oncology Group (COG) AALL0622 trial reported in the Journal of Clinical Oncology, Slayton et al found that adding dasatinib (Sprycel) to intensive chemotherapy produced good long-term outcomes in pediatric/young adult patients with newly diagnosed Philadelphia ...
In a phase II trial reported in The Lancet Oncology, Cortes et al found that the next-generation FLT3 inhibitor quizartinib had good activity in patients with relapsed or refractory acute myeloid leukemia (AML), with greater activity in patients with FLT3-ITD mutations. Study Details The study...
In a study of National Cancer Database data reported in Blood Advances, Bhatt et al found that 25% of patients with newly diagnosed acute myeloid leukemia (AML) did not receive initial chemotherapy, despite evidence that chemotherapy is associated with a survival benefit and improvement in symptoms ...
RESEARCHERS AT the University of California (UC), Davis, have shown that patients with acute myeloid leukemia (AML) who received their care at a National Cancer Institute (NCI) cancer center in California had a dramatically reduced risk of early mortality. Using data from the California Cancer...
As reported at the 2018 ASCO Annual Meeting and in The New England Journal of Medicine by DiNardo et al, early-phase testing has shown activity of ivosidenib, an oral small-molecule inhibitor of mutant IDH1, in patients with IDH1-mutated relapsed or refractory acute myeloid leukemia (AML). IDH1...
Ivosidenib, an isocitrate dehydrogenase-1 (IDH1) inhibitor, yielded durable and molecular remissions in some patients with IDH1-mutated advanced relapsed or refractory acute myeloid leukemia (AML). At a dose of 500 mg/d, ivosidenib was associated with a low frequency of grade 3 or higher...