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Showing 151 - 200AACR 2019: Gilteritinib in Patients With FLT3-Mutated Acute Myeloid Leukemia
Treatment with the FLT3-targeted therapeutic gilteritinib improved survival for patients with relapsed or refractory acute myeloid leukemia (AML) harboring an FLT3 mutation compared with standard chemotherapy regimens, according to results from the phase III ADMIRAL trial presented by Perl et al at ...
FDA Pipeline: Mammography Policies, Designations for Leukemias and Myelodysplastic Syndrome
This week, the U.S. Food and Drug Administration (FDA) announced policy changes to modernize mammography policies and issued a Breakthrough Therapy designation, an Orphan Drug designation, and an investigational new drug application. FDA Advances Policy Changes to Modernize Mammography Services...
Venetoclax Plus Low-Dose Cytarabine in Older Patients With Previously Untreated AML Ineligible for Intensive Chemotherapy
In a phase Ib/II trial reported in the Journal of Clinical Oncology, Wei et al found that the combination of venetoclax and low-dose cytarabine produced a high response rate in previously untreated older patients with acute myeloid leukemia (AML) who were ineligible for intensive chemotherapy. In...
Neil P. Shah, MD, PhD, on CML: NCCN Guidelines Updates on Discontinuing Tyrosine Kinase Inhibitor Therapy
Neil P. Shah, MD, PhD, of the UCSF Helen Diller Family Comprehensive Cancer Center, discusses the feasibility of discontinuing tyrosine kinase inhibitor therapy in select patients with chronic phase chronic myeloid leukemia outside of clinical trials.
Frederick L. Locke, MD, on Innovative CAR-T Cell Therapies: The Patient Experience
Frederick L. Locke, MD, of the H. Lee Moffitt Cancer Center and Research Institute, discusses recent approvals of chimeric antigen receptor T-cell therapies in leukemia and lymphoma, and how clinicians are using infrastructure, navigation, and early referrals to maximize response and minimize...
FDA Pipeline: Assay Approval, Breakthrough Designations for AI Technology and CLL, and More
In the past week, the U.S. Food and Drug Administration (FDA) approved a companion diagnostic assay, granted Breakthrough Device and Breakthrough Therapy designations, and extended the review period of a proposed treatment. The agency also published four draft guidances and one final guidance...
Effect of Hematopoietic Stem Cell Transplantation on Outcome in Pediatric Hypodiploid B-ALL
In a report from the Children’s Oncology Group (COG) in the Journal of Clinical Oncology, McNeer et al found that hematopoietic stem cell transplantation (HSCT) did not improve outcomes in pediatric patients with hypodiploid B-lymphoblastic leukemia (B-ALL). Study Details The study was a...
FDA Pipeline: Updates on Treatments for Cervical Cancer, Myelofibrosis, Chemotherapy-Induced Nausea and Vomiting, and More
The FDA recently issued announcements on a Fast Track designation, a Priority Review, two supplemental new drug applications, an investigational new drug application, and a marketing clearance. The agency also released a safety communication on cancer-related surgery. Fast Track Designation for...
Stefan O. Ciurea, MD, on Infusing High Doses of Natural Killer Cells: An Enhanced Antitumor Effect
Stefan O. Ciurea, MD, of The University of Texas MD Anderson Cancer Center, discusses the enhanced antitumor effect and lower viral reactivation that result from high doses of natural killer cells infused after haploidentical transplantation, with no excess graft-vs-host disease, a low relapse rate ...
FDA Pipeline: Priority Reviews in Solid Tumors and Lymphoma; Plus an sNDA in Acute Myeloid Leukemia
Over the past week, the U.S. Food and Drug Administration (FDA) granted multiple Priority Reviews and accepted a supplemental new drug application: Priority Review for Entrectinib in NTRK Fusion–Positive Solid Tumors and Metastatic, ROS1-Positive NSCLC This week, the FDA accepted new drug...
ERG Gene Variations and Risk of ALL in Hispanic Children
Scientists have identified genetic variations in a fourth gene that are associated with an increased risk of acute lymphoblastic leukemia (ALL) in Hispanic children. These findings were published by Qian et al in Blood. The gene is ERG, a transcription factor that is also...
Treatment Outcomes for Children With Hypodiploid Acute Lymphoblastic Leukemia
In a retrospective study reported in the Journal of Clinical Oncology, Pui et al found that minimal residual disease (MRD)-negative status, high hypodiploidy with 44 chromosomes, and MRD-stratified treatment were associated with improved outcomes among children treated for newly diagnosed...
FDA Approves Ibrutinib in Combination With Obinutuzumab in Treatment-Naive CLL/SLL
Today, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica), a Bruton's tyrosine kinase inhibitor, in combination with obinutuzumab in treatment-naive patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This is the first approval of a...
Combination Azacitidine and Lenalidomide as Salvage Therapy for Relapsed AML After Allogeneic Stem Cell Transplantation
In a phase I trial reported in the Journal of Clinical Oncology, Craddock et al found evidence that the sequential combination of azacitidine and lenalidomide may be an effective salvage therapy in patients with acute myeloid leukemia (AML) relapsing after allogeneic stem cell transplantation...
Newly Defined Subtypes of B-Cell Acute Lymphoblastic Leukemia
Investigators have identified multiple new subtypes of the most common childhood cancer, B-cell acute lymphoblastic leukemia (ALL)—research that has the potential to improve the diagnosis and treatment of high-risk patients. Researchers used integrated genomic analysis, including...
Study Finds Elevated Risk of MDS and AML After Chemotherapy for Most Solid Tumors
Findings from a new study by researchers at the National Cancer Institute (NCI) show that patients treated with chemotherapy for most solid tumors from 2000 to 2014 experienced an increased risk of therapy-related myelodysplastic syndrome/acute myeloid leukemia (MDS/AML). The study, which used U.S. ...
FDA Expands Indication for Dasatinib to Pediatric Patients With Ph+ ALL in Combination With Chemotherapy
On January 2, the U.S. Food and Drug Administration (FDA) expanded the indication for dasatinib (Sprycel) tablets to include the treatment of pediatric patients 1 year of age and older with newly diagnosed Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL) in...
FDA Approves Calaspargase Pegol-mknl for Pediatric and Young Adult Patients With ALL
On December 20, 2018, the U.S. Food and Drug Administration (FDA) approved calaspargase pegol-mknl (Asparlas), an asparagine-specific enzyme, as a component of a multiagent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients aged 1 month to...
Nuclear Excision Repair as a Possible Predictor of Early Relapse in Pediatric ALL
Researchers recently discovered that by testing the level of nucleotide excision repair (NER) gene expression, pediatric oncologists may be able to determine the likelihood of early relapse (less than 3 years) in patients with acute lymphoblastic leukemia (ALL). These findings were published by...
First-Line Ibrutinib With or Without Rituximab vs Rituximab/Bendamustine in Older Patients With CLL
In a phase III trial reported at the recent American Society of Hematology Annual Meeting & Exposition and in The New England Journal of Medicine by Woyach et al, ibrutinib (Imbruvica) and ibrutinib/rituximab (Rituxan) were associated with superior progression-free survival vs...
MURANO Trial Follow-up: MRD and Prognosis With Fixed Duration of Venetoclax/Rituximab in Relapsed or Refractory CLL
As reported in the Journal of Clinical Oncology by Kater et al, high undetectable minimal residual disease (MRD) rates persisted after the end of venetoclax (Venclexta)/rituximab (Rituxan) treatment in the phase III MURANO trial in relapsed or refractory chronic lymphocytic leukemia (CLL), and were ...
Reducing Infections in Patients With AML Receiving Induction and Reinduction Chemotherapy
In a report in the Journal of Oncology Practice, Morris et al described an initiative that has been successful in reducing the incidence of invasive fungal infections in patients with acute myeloid leukemia (AML) receiving induction and reinduction therapy at the University of Virginia Health...
FDA Pipeline: New Priority Reviews, Designations, and Clearances, Plus Statements on Genetic Testing and Class Labeling
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Priority Review for Atezolizumab in Combination With Chemotherapy for the Initial Treatment of Extensive-Stage SCLC The FDA accepted a supplemental biologics license application...
ASH 2018: Researchers Identify Mutation in BCL2 Protein That Causes Resistance to Venetoclax in Progressive CLL
Investigators from Australia have identified a genetic mutation that causes resistance to the targeted drug venetoclax (Venclexta) in patients with chronic lymphocytic leukemia (CLL), according to research presented by Blombery et al at the 2018 American Society of Hematology (ASH) Annual Meeting...
ASH 2018: Ibrutinib Plus Rituximab vs Standard Chemoimmunotherapy in Younger Patients With Treatment-Naive CLL
A 6-month course of chemotherapy-based treatment with FCR (intravenous fludarabine and cyclophosphamide plus rituximab [Rituxan]) has historically been the most effective treatment for chronic lymphocytic leukemia (CLL), especially in patients 70 years of age and younger. However, results from a...
Tait D. Shanafelt, MD, on CLL: Results From a Trial of the ECOG-ACRIN Cancer Research Group
Tait D. Shanafelt, MD, of Stanford University, discusses phase III study findings on ibrutinib-based therapy vs standard fludarabine, cyclophosphamide, and rituximab chemoimmunotherapy in untreated younger patients with chronic lymphocytic leukemia (Abstract LBA4).
Shaji K. Kumar, MD, on Newly Diagnosed Multiple Myeloma: Treatment Trial Results
Shaji K. Kumar, MD, of the Mayo Clinic, discusses phase III findings on daratumumab plus lenalidomide and dexamethasone vs lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who are ineligible for transplant (Abstract LBA2).
Saar I. Gill, MD, PhD, on CLL: Trial Results on Anti-CD19 CAR T Cells
Saar I. Gill, MD, PhD, of the University of Pennsylvania, discusses findings from a prospective clinical trial on the high response rate in patients with chronic lymphocytic leukemia who received a combination therapy of CAR T cells plus ibrutinib (Abstract 298).
Julie Vose, MD, MBA, and Merav Bar, MD, on CAR T-Cell Therapy: Late Effects of CD19-Targeted Treatment
Julie Vose, MD, MBA, of the University of Nebraska Medical Center, and Merav Bar, MD, of the Fred Hutchinson Cancer Research Center, discuss study findings on the long-term effects in people with relapsed or refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia who received CD19-targeted ...
Andreas Burchert, MD, on AML: Results From the Sormain Trial
Andreas Burchert, MD, of the Philipps University of Marburg, discusses study findings on sorafenib as maintenance therapy after allogeneic stem cell transplantation for FLT3-ITD–positive acute myeloid leukemia.
ASH 2018: Rapid Genetic Screening Shows Feasibility of Precision Medicine for AML
A new study demonstrated it is feasible for health-care providers to determine which molecular subtype of acute myeloid leukemia (AML) a patient has before beginning treatment and to use this information to pick an approach that best matches the individual. The results, presented by Burd et al at...
Jennifer Ann Woyach, MD, on CLL: Results From the Alliance North American Intergroup Study
Jennifer Ann Woyach, MD, of The Ohio State University, discusses trial findings on ibrutinib alone or in combination with rituximab compared with bendamustine plus rituximab in untreated older people with chronic lymphocytic leukemia (Abstract 6).
ASH 2018: Hematopoietic Stem Cell Transplant After CD19 CAR T-Cell Therapy in ALL
In a new study presented by Summers et al at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 967), patients with acute lymphoblastic leukemia (ALL) who received a first stem cell transplant after CD19 chimeric antigen receptor (CAR) T-cell therapy were less...
ASH 2018: Checkpoint Inhibitors Plus CAR T-Cell Therapy in Relapsed ALL
CD19-directed chimeric antigen receptor (CAR) T-cell therapy has been shown to be effective in patients with relapsed B-cell acute lymphocytic leukemia (B-ALL). However, in some patients, the antitumor effects of CAR T-cell treatment are short-lived, which may, in part, be caused by a reaction of...
ASH 2018: Concurrent Ibrutinib May Improve Outcomes, Reduce Toxicity of CAR T-Cell Therapy in Relapsed or Refractory CLL
For patients with difficult-to-treat chronic lymphocytic leukemia (CLL), continuing to take ibrutinib (Imbruvica) before, during, and after receiving chimeric antigen receptor (CAR) T-cell therapy may be associated with less severe adverse effects and better responses compared with outcomes for a...
ASH 2018: ELIANA Trial: Tisagenlecleucel in Pediatric and Young Adult Patients With ALL
A single infusion of tisagenlecleucel (Kymriah) in pediatric and young adult patients with relapsed or treatment-resistant acute lymphocytic leukemia (ALL) continues to be highly effective in most patients, without the need for additional therapies. This latest analysis of the ELIANA trial results...
ASH 2018: Ibrutinib Alone or in Combination With Rituximab vs Bendamustine Plus Rituximab in Older Patients With CLL
A new study presented by Woyach et al at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 6) showed that older patients with chronic lymphocytic leukemia (CLL) have a significantly lower rate of disease progression if treated with ibrutinib rather than...
ASH 2018: Azacitidine With Nivolumab Plus Ipilimumab vs Azacitidine Plus Nivolumab in Relapsed or Refractory AML
A triplet therapy combining two immune checkpoint inhibitors with the standard of care azacitidine has shown promising results for treatment of relapsed or refractory acute myeloid leukemia (AML), according to the findings of a phase II study conducted at The University of Texas...
MRD-Guided Azacitidine Treatment in Myelodysplastic Syndrome and Acute Myeloid Leukemia
In a German phase II trial (RELAZA2) reported in The Lancet Oncology, Platzbecker et al found that minimal residual disease (MRD)–guided treatment with azacitidine was successful in preventing hematologic relapse in patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia...
FDA Approves Gilteritinib for Relapsed or Refractory FLT3-Mutated AML
Today, the U.S. Food and Drug Administration (FDA) approved gilteritinib (Xospata) for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. The FDA also approved an expanded indication for a companion ...
FDA Approves Venetoclax Combination for Adults With AML
On November 21, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to venetoclax (Venclexta) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older or...
FDA Approves Glasdegib for Patients With Newly Diagnosed AML Who Cannot Undergo Intensive Chemotherapy
Today, the U.S. Food and Drug Administration (FDA) approved glasdegib (Daurismo) tablets to be used in combination with low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or with comorbidities that may preclude the use of ...
Azacitidine Plus Nivolumab in Relapsed or Refractory AML
A combination of the chemotherapy drug azacitidine with the immune checkpoint inhibitor nivolumab (Opdivo) demonstrated an encouraging response rate and overall survival in patients with relapsed or refractory acute myeloid leukemia (AML), according to findings from a phase II study published...
Suleika Jaouad on Making the Most of a Life Interrupted: A Young Adult Perspective on Cancer
Suleika Jaouad, an Emmy Award–winning writer, advocate, and cancer survivor who was diagnosed at age 22 with myelodysplastic syndrome and acute myeloid leukemia, discusses what she has learned about coping with cancer, learning from it, and growing beyond it.
Dysregulation of Immune Pathways in AML Relapse After Allogeneic HSCT
In a study reported in The New England Journal of Medicine, Christopher et al found that acute myeloid leukemia (AML) relapse after allogeneic hematopoietic stem cell transplantation (HSCT) was accompanied by dysregulation of immune pathways, including downregulation of major histocompatibility...
Effect of Early Cardiotoxicity on Outcomes in Pediatric AML
In an analysis from the Children’s Oncology Group AAML0531 trial reported in the Journal of Clinical Oncology, Getz et al found that early treatment-related cardiotoxicity may be associated with poorer event-free and overall survival in pediatric acute myeloid leukemia (AML). Study Details...
Duvelisib vs Ofatumumab in Relapsed or Refractory CLL/SLL
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...
Adding Lomustine to Conventional Chemotherapy in Older Patients With AML Without Unfavorable Cytogenetics
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....
Lack of Clinical Trial Participation and Shorter Duration of Therapy Linked to Disease Relapse in AYAs With Leukemia
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,...
FDA Authorizes First Next-Generation Sequencing–Based Test to Detect Minimal Residual Disease in B-Cell ALL or Multiple Myeloma
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...
