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 ...
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...
Results from the phase III QuANTUM-R study of single-agent quizartinib in relapsed or refractory acute myeloid leukemia (AML) were presented by Cortes et al at the 23rd Annual Congress of the European Hematology Association (EHA) (Abstract LB2600). Study Findings QuANTUM-R study results showed...
Investigational data from a new analysis of undetectable minimal residual disease (MRD) rates from the phase III MURANO trial of venetoclax (Venclexta, a first-in-class oral B-cell lymphoma 2 [BCL2] inhibitor) in combination with rituximab (Rituxan) in patients with relapsed or refractory chronic...
Data from the final analysis of the CLL11 study evaluating obinutuzumab (Gazyva)-based treatment in previously untreated chronic lymphocytic leukemia (CLL) was presented by Goede et al during the Presidential Symposium at the 23rd Annual Congress of the European Hematology Association (EHA)...
Preliminary data from Zella 201—an ongoing phase II study evaluating the efficacy and safety of alvocidib, a potent cyclin-dependent kinase 9 (CDK9) inhibitor, in combination with cytarabine and mitoxantrone in patients with relapsed or refractory MCL-1–dependent acute myeloid leukemia...
The phase III iLLUMINATE (PCYC-1130) trial recently met its primary endpoint of improvement in progression-free survival. The study evaluated ibrutinib (Imbruvica) in combination with obinutuzumab (Gazyva) in patients with previously untreated chronic lymphocytic leukemia or small lymphocytic...
In a letter to the editor in The New England Journal of Medicine, Ratner et al describe rapid progression of adult T-cell leukemia/lymphoma (ATLL) in three consecutive patients receiving programmed cell death protein 1 (PD-1) inhibitor therapy with nivolumab (Opdivo). As stated by the authors,...
On June 8, the U.S. Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. MURANO Approval was based ...
Courtney Denton Dinardo, MD, of The University of Texas MD Anderson Cancer Center, discusses findings on the durable response with venetoclax in combination with decitabine or azacitidine in elderly patients with acute myeloid leukemia (Abstract 7010).
Peter Hillmen, MB, ChB, of St James’s University Hospital, discusses phase III study findings on minimal residual disease negativity with venetoclax plus rituximab in relapsed or refractory chronic lymphocytic leukemia (Abstract 7508).
Julie M. Vose, MD, MBA, of the University of Nebraska Medical Center, and William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, discuss phase II findings on ibrutinib plus venetoclax in first-line treatment of chronic lymphocytic leukemia (Abstract 7502).
Rita Elias Assi, MD, of The University of Texas MD Anderson Cancer Center, discusses the impact of next-generation sequencing on treatment selection in acute myeloid leukemia (Abstract 103).
Robert J. Kreitman, MD, of the National Cancer Institute, discusses findings on moxetumomab pasudotox in heavily pretreated patients with relapsed or refractory hairy cell leukemia (Abstract 7004).
The U.S. Food and Drug Administration (FDA) has accepted, with Priority Review, a new drug application (NDA) for gilteritinib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) and a mutation in the FLT3 gene, as detected by an FDA-approved test....
In an interim analysis of a European trial reported in The Lancet Oncology, Saussele et al found that discontinuation of tyrosine kinase inhibitor therapy in patients with chronic myeloid leukemia (CML) with deep molecular response was associated with good molecular relapse-free survival,...
In a study reported in the Journal of Clinical Oncology, Morita et al found that clearance of somatic mutations at complete remission—particularly those in nonpreleukemic genes—was associated with improved outcomes in previously untreated patients with acute myeloid leukemia (AML)....
In an article published in the Journal of Clinical Oncology, Stilgenbauer et al reported findings from the full population of the phase II trial that supported the 2016 approval of venetoclax (Venclexta) in the treatment of previously treated chronic lymphocytic leukemia (CLL) with 17p deletion....
Adolescents and young adults (AYAs) with acute lymphocytic leukemia (ALL) have a survival advantage if they receive treatment at a pediatric cancer center vs an adult center, according to a study published by Muffly et al in Blood Advances. The findings also suggest that treatment at a center...
In an analysis of the UK National Cancer Research Institute AML17 trial reported in the Journal of Clinical Oncology, Freeman et al found that detection of measureable/minimal residual disease (MRD) after first induction in acute myeloid leukemia (AML) may be prognostically equivalent to partial...
On April 9, the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review a new drug application (NDA) for the oral agent duvelisib, a first-in-class, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma. The NDA is seeking full approval for duvelisib in...
In a study reported in The New England Journal of Medicine, Jongen-Lavrencic et al found that molecular minimal residual disease identified by next-generation sequencing during complete remission was associated with increased risk of relapse and mortality over 4 years of follow-up in patients with...
On April 3, the U.S. Food and Drug Administration (FDA) accepted a Biologics License Application (BLA) for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukemia (HCL) who have received at ...
In the phase III MURANO trial reported in The New England Journal of Medicine by Seymour et al, the combination of the BCL2 inhibitor venetoclax (Venclexta) with rituximab (Rituxan) markedly improved progression-free survival vs bendamustine plus rituximab in patients with relapsed or refractory...
The U.S. Food and Drug Administration granted accelerated approval to blinatumomab (Blincyto) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). In patients who have achieved remission after...
In a study reported in the Journal of Clinical Oncology, Stanulla et al found that a gene profile including somatic deletions in the lymphoid transcription factor–coding gene IKZF1 and deletions in other genes was associated with minimal residual disease (MRD)-dependent very-poor prognosis...
Bijal D. Shah, MD, of the H. Lee Moffitt Cancer Center, discusses key studies of CAR T-cell therapy in relapsed B-cell ALL and the adverse events that this treatment may cause.
Today, the U.S. Food and Drug Administration (FDA) expanded the indication for nilotinib (Tasigna) to include treatment of first- and second-line pediatric patients 1 year of age or older with Philadelphia chromosome–positive chronic myeloid leukemia in the chronic phase. In the United...
Ellin Berman, MD, of Memorial Sloan Kettering Cancer Center, discusses the effects of TKI therapy on fetal development, its impact on pregnancy outcomes, and how to develop an effective treatment plan.
In an analysis of two pooled studies reported in JAMA Oncology, O’Brien et al found that a complete response to ibrutinib (Imbruvica) in the treatment of chronic lymphocytic leukemia was more likely in patients receiving the agent as first-line therapy and in those without bulky disease....
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 in the Journal of Clinical Oncology by Gore et al, a phase II trial has shown high response rates with dasatinib treatment in pediatric patients with Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia in chronic phase (CML-CP). Findings in the trial supported the...
On February 28, Shire announced that the U.S. Food and Drug Administration (FDA) accepted the company’s biologics license application (BLA) for calaspargase pegol (Cal-PEG; SHP663). The investigational-stage compound is being reviewed as a component of a multiagent chemotherapeutic regimen...
On February 15, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for ivosidenib (AG-120) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation. The NDA was granted Priority Review...
On February 14, Amgen announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the supplemental biologics license application (sBLA) for blinatumomab (Blincyto) for the treatment of patients with minimal residual disease...
Updated results from the ELIANA clinical trial of tisagenlecleucel (Kymriah), formerly CTL019, in relapsed or refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL) have been published by Maude et al in The New England Journal of Medicine. New data include...
In a single-center phase II study reported in The Lancet Oncology, Kantarjian et al found that the addition of inotuzumab ozogamicin (Besponsa) to low-intensity chemotherapy produced promising outcomes in older patients with newly diagnosed Philadelphia chromosome–negative acute lymphoblastic ...
Kristen Fousek, PhD Candidate at Baylor College of Medicine, discusses her preclinical work on targeting CD19-negative relapsed B-cell acute lymphoblastic leukemia, using CAR T cells that target three antigens simultaneously, a technique that addresses the growing problem of relapse (Abstract 121).
In a study reported in the Journal of Clinical Oncology, Qian et al found that loss-of-function germline TP53 variants increase the risk of childhood B-cell acute lymphoblastic leukemia (ALL), as well as the risk of poorer response to therapy and second malignancies. Study Details In the study,...
On January 15, the U.S. Food and Drug Administration (FDA) approved the use of arsenic trioxide (Trisenox) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17)...
In a study reported in the Journal of Clinical Oncology, Molenaar et al found that radioiodine treatment for well-differentiated thyroid cancer was associated with an increased risk of acute myeloid leukemia (AML) and chronic myeloid leukemia (CML) compared with thyroidectomy alone. Study Details ...
An interim analysis of a phase II trial reported by Jones et al in The Lancet Oncology indicates that venetoclax (Venclexta) produces a response in a high proportion of patients with chronic lymphocytic leukemia progressing on or after ibrutinib (Imbruvica) treatment. Study Details The study...
On December 22, the U.S. Food and Drug Administration (FDA) updated the product label for nilotinib (Tasigna) to include information for providers about how to discontinue the drug in certain patients. Nilotinib, first approved by the FDA in 2007, is indicated for the treatment of patients with...
On December 19, the Institute for Clinical and Economic Review (ICER) released a Draft Evidence Report assessing the comparative clinical effectiveness and value of tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta). The draft report, along with draft voting...
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bosutinib (Bosulif) for treatment of patients with newly diagnosed chronic-phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML). BFORE Trial Approval was based on data from ...
At the 59th American Society of Hematology (ASH) Annual Meeting & Exposition, Hunger et al presented data from the phase II CA180-372 study in pediatric patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL) treated with dasatinib (Sprycel) added ...
In the phase III MURANO trial, treatment with the targeted cancer drug venetoclax (Venclexta) in combination with rituximab (Rituxan) more than doubled the likelihood that patients with chronic lymphocytic leukemia (CLL) would survive for 2 years without cancer progression, compared to treatment...
In the first comprehensive analysis of clinical trial enrollment among older adults with blood cancers, researchers from the U.S. Food and Drug Administration (FDA) found significant gaps in participation among those aged 75 and older when considered against the incidence of these malignancies in...
John F. Seymour, MBBS, PhD, of the Peter MacCallum Cancer Centre, discusses an interim analysis of venetoclax plus rituximab vs bendamustine plus rituximab in patients with relapsed/refractory chronic lymphocytic leukemia (Abstract LBA-2).
Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center, discusses phase II study results on combined venetoclax and ibrutinib for patients with previously untreated high-risk and relapsed/refractory chronic lymphocytic leukemia (Abstract 429).