Modernized Treatment Approaches for Childhood Cancers Are a Result of COG Clinical Trials
Significant progress has been made with childhood cancer, especially with the efforts of Children's Oncology Group (COG), but some areas still need attention, Doug Hawkins, MD, COG chair, a National Cancer Institute (NCI)-funded network of researchers and hospitals, explained in a September 2022 interview with NCI.
FDA Approves Second Dosing Regimen for Asparaginase Erwinia Chrysanthemi (Recombinant)-Rywn
On November 18, 2022, the U.S. Food and Drug Administration approved a Monday-Wednesday-Friday dosing option for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze®). Under the alternative regimen, patients receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings and 50 mg/m2 intramuscularly on Friday afternoons. It also is approved at a dose of 25 mg/m2 intramuscularly every 48 hours.
Naive T-Cell Depletion Prevents Chronic GVHD in Transplantation Survivors
A novel stem cell transplantation strategy reduces both the incidence and severity of chronic graft-versus-host disease (GVHD) in patients with acute leukemia, researchers reported in the Journal of Clinical Oncology. The investigational treatment removes naïve T cells from donor cells before transplanting into patients.
FDA Approves Ivosidenib in Combination With Azacitidine for Newly Diagnosed Acute Myeloid Leukemia
On May 25, 2022, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo®) in combination with azacitidine for patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 variant as detected by an FDA-approved test in adults aged 75 years or older or those who have comorbidities that preclude use of intensive induction chemotherapy.
FDA Approves Azacitidine for Newly Diagnosed Juvenile Myelomonocytic Leukemia
On May 20, 2022, the U.S. Food and Drug Administration (FDA) approved azacitidine (Vidaza®) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML).
Oncology Drug Reference Sheet: Ivosidenib
Adding to its earlier approvals for use in adults with acute myeloid leukemia (AML), on August 25, 2021, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo®) for adults with previously treated, locally advanced or metastatic cholangiocarcinoma. Cholangiocarcinoma, or cancer of the bile ducts, is a rare cancer, and ivosidenib is the only currently approved agent for patients with an IDH1 variant.
The Case of the Post-Transplant Pulmonary Problem
Benjamin, your 28-year-old patient with acute lymphoblastic leukemia, received a 10/10 matched, unrelated donor for his allogeneic hematopoietic stem cell transplantation. Two months post-transplant, Benjamin developed grade 4 skin and gastrointestinal graft-versus-host disease.
FDA Approves Asciminib for Philadelphia Chromosome-Positive Chronic Myeloid Leukemia
On October 29, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to asciminib (Scemblix®) for patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) who were previously treated with two or more tyrosine kinase inhibitors (TKIs). FDA also approved asciminib for adult patients with Ph+ CML in CP with the T315I variation.
FDA Approves Brexucabtagene Autoleucel for Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
On October 1, 2021, the U.S. Food and Drug Administration (FDA) approved brexucabtagene autoleucel (Tecartus™) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
BTK Inhibitor Effective for Relapsed Hairy Cell Leukemia
Ibrutinib produces durable disease control for patients with high-risk hairy cell leukemia, a rare cancer, who have relapsed and for whom standard purine analogues are not a feasible therapeutic option, according to study results published in Blood.
Targeted Therapy Drug Shows Promise in CLL
Pirtobrutinib, an investigational, third-generation Bruton tyrosine kinase (BTK) inhibitor, offered response rates of 60% or higher in most groups of heavily pretreated patients with chronic lymphocytic leukemia (CLL), even those who’ve received other BTK inhibitors as previous treatment, researchers reported in Lancet.
The Case of the Targeted Therapy Toxicity
Tyrone is a 74-year-old man with a history of acute myeloid leukemia (AML), type 2 diabetes, and hypertension who was admitted to the hospital after lab results revealed 40% circulating blasts in his peripheral blood that was concerning for relapsed disease. He was diagnosed with AML three years ago and achieved remission after treatment with a hypomethylating agent.
The Case of the Cord Blood Match
Zhang is a 67-year-old man who had no history of medical concerns until he was hospitalized for pneumonia. A complete blood count taken during his workup for pneumonia showed pancytopenia, and a biopsy confirmed a diagnosis of acute myeloid leukemia. After multiple rounds of induction therapy, Zhang's bone marrow biopsy showed minimal residual disease and he entered remission. His oncologist recommends an allogeneic hematopoietic stem cell transplant as soon as possible because of the disease's aggressive nature, but he has no match in the registry.
FDA Approves Azacitidine Tablets for Acute Myeloid Leukemia
On September 1, 2020, the U.S. Food and Drug Administration (FDA) approved azacitidine tablets for continued treatment of patients with acute myeloid leukemia who achieved first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy and who are unable to complete intensive curative therapy.
FDA Approves Ibrutinib Plus Rituximab for Chronic Lymphocytic Leukemia
On April 21, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of ibrutinib (Imbruvica®) to include its combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
Survival Gains Make CAR T-Cell Therapy Cost-Effective for Pediatric Leukemia
When evaluated based on the cost per life-year gained, the chimeric antigen receptor (CAR) T-cell immunotherapy drug tisgenlecleucel is considered cost effective in pediatric B-cell acute lymphoblastic leukemia, researchers reported in a new study. The findings were published in JAMA Pediatrics.
Patient Stress Linked to More Advanced Leukemia
Patients with chronic lymphocytic leukemia (CLL) who experience more stress also have more cancer cells in their blood and elevated levels of three other advanced disease markers, according to results of a study published in Cancer. It is the first study to link stress with biologic disease markers in patients with CLL.
Despite Low Disease Recurrence, Long-Term AML Survivors Require Preventative Care
Many patients with acute myeloid leukemia (AML) achieve complete remission (CR) after induction chemotherapy; however, just 30% of patients maintain CR for three years or longer. Long-term outcomes for those who do maintain CR are largely unknown. Results from a new study have shown that new medical problems frequently occur, and patients require routine surveillance and preventative measures. Catherine Kendall Major, BS, of the MD Anderson Cancer Center in Lakeland, TN, discussed the findings at the ASH Annual Meeting on December 3, 2018.
Study Provides Guidance for Transfusion Practices in Patients With Leukemia Who Experience ICH
Intracranial hemorrhage (ICH) is a common complication in patients with acute leukemia and is associated with significant morbidity and mortality. Information on platelet transfusion practice in patients following ICH is limited, so researchers assessed clinical features and outcomes to better guide transfusion practices after ICH. Shannon Nixon, NP, of the Princess Margaret Cancer Centre at the University of Toronto, discussed the findings at the ASH Annual Meeting on December 3, 2018.
Education May Improve Adherence, Quality of Life for Patients With AML
Patients and families can make better healthcare decisions that are consistent with patients’ needs, values, and preferences when they are more informed and educated about the disease, according to study findings that Anne C. Roc, PhD, of PlatformQ Health in Needham, MA, discussed at the ASH Annual Meeting on December 3, 2018.
Screening for DDX41 Mutation Can Guide Treatment Decisions for Myeloid Neoplasms
Germline mutations in DDX41 may increase a patient’s lifetime risk of late-onset myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Identification of this germline mutation leads to more timely and appropriate care for patients with myeloid neoplasms, according to a study. Sarah Bannon, MS, of the University of Texas MD Anderson Cancer Center in Houston, discussed the findings at the ASH Annual Meeting on December 2, 2018.
FDA Approves Gilteritinib for Relapsed, Refractory AML With an FLT3 Mutation
On November 28, 2018, the U.S. Food and Drug Administration (FDA) approved gilteritinib for treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.
FDA Approves Glasdegib for AML in Adults Aged 75 or Older or Who Have Comorbidities
On November 21, 2018, the U.S. Food and Drug Administration (FDA) approved glasdegib in combination with low-dose cytarabine, for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy.
Infusion Technique Reduces AEs in Patients With ALL Receiving PEG-Asparaginase
Asparaginase is part of treatment for acute lymphocytic leukemia (ALL) and is associated with improved outcomes in those who complete this course of treatment. Despite the necessity of PEG-asparaginase, 20%–30% of patients can experience toxicities.
FDA Approves Duvelisib for Adult Patients With Relapsed or Refractory CLL or SLL
On September 24, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to duvelisib for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.
FDA Approves Moxetumomab Pasudotox-tdfk for Hairy Cell Leukemia
On September 13, 2018, the U.S. Food and Drug Administration (FDA) approved moxetumomab pasudotox-tdfk (Lumoxit), a CD22-directed cytotoxin indicated for adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including treatment with a purine nucleoside analog.
FDA Approves Ivosidenib for Relapsed or Refractory AML
On July 20, 2018, the U.S. Food and Drug Administration (FDA) approved ivosidenib for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.
FDA Approves Venetoclax for CLL or SLL
On June 8, 2018, 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.
FDA Grants Accelerated Approval to Blinatumomab for B-Cell Precursor ALL
On March 29, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to blinatumomab (Blincyto®) 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 (MRD) greater than or equal to 0.1%.
FDA Approves Nilotinib for Pediatric Patients With Chronic Phase Ph+ CML
On March 22, 2018, the U.S. Food and Drug Administration (FDA) approved nilotinib for pediatric patients 1 year of age or older with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor therapy.
FDA Grants Accelerated Approval to Bosutinib for Treatment of Newly-Diagnosed PH+ CML
On December 19, 2017, the U.S. Food and Drug Administration granted accelerated approval to bosutinib for treatment of patients with newly-diagnosed chronic phase Philadelphia chromosome positive chronic myelogenous leukemia.
Better Symptom Management Is Needed for Patients With CML
Patients with chronic myeloid leukemia (CML) often experience symptoms and treatment-related adverse events (AEs) that are chronic and may require care from an interdisciplinary team. A study sought to assess symptom burden, palliative care needs, and experiences with healthcare team communication in this patient population. Alexandra K. Zaleta, PhD, at the Research and Training Institute, Cancer Support Community in Philadelphia, PA, discussed the findings at the ASH Annual Meeting.
Real-World Findings for Ibrutinib in Patients With CLL: Toxicities, Discontinuations, and More
Ibrutinib is approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic lymphocytic leukemia (CLL). Researchers sought to study real-world outcomes related to adverse events (AEs), treatment discontinuation, outcomes, and subsequent therapies in those treated with frontline ibrutinib. Anthony R. Mato, MD, at the University of Pennsylvania Abramson Cancer Center in Philadelphia, PA, discussed the findings at the ASH Annual Meeting.
Statins Enhance Venetoclax Response in CLL and MM
Venetoclax—an oral, small-molecule BCL-2 inhibitor—is approved by the U.S. Food and Drug Administration for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) in those with del(17p) mutation. Statins, which are used to lower cholesterol, have shown a potential to induce apoptosis in various cancer cell lines, and evidence suggests a synergism when combined with BCL-2 inhibition. Based on this, researchers conducted a post-hoc analysis to see whether statins enhance the activity of venetoclax in patients with CLL or multiple myeloma (MM). Andrew W. Roberts, MS, at AbbVie Inc., in North Chicago, IL, discussed the findings at the ASH Annual Meeting.
Patients With CLL Report Worse QoL and Other Factors
Researchers assessed how patients with chronic lymphocytic leukemia (CLL) describe quality of life (QoL) compared to other U.S. populations, as well as the effects on daily living, finances, and professional and family relationships. Joanne S. Buzaglo, PhD, at the Research and Training Institute, Cancer Support Community in Philadelphia, PA, discussed the findings at the ASH Annual Meeting.
Study Compares Adverse Event Profile for CPX-351 and Conventional 7+3 for AML
CPX-351 is a dual-drug liposomal encapsulation of cytarabine and daunorubicin that delivers a synergistic drug ratio. In a randomized, phase III study, researchers evaluated induction therapy with CPX-351 versus conventional cytarabine/daunorubicin (referred to as 7+3 regimen) in adults aged 60–75 years with newly diagnosed, treatment-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes. Bruno C Medeiros, MD, at Stanford University School of Medicine in California, discussed the findings at the ASH Annual Meeting.
FDA Approves Dasatinib for Pediatric Patients With CML
On November 9, 2017, U.S. the Food and Drug Administration (FDA) granted regular approval to dasatinib (Sprycel®, Bristol-Myers Squibb Co.) for the treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase.
FDA Approves Gemtuzumab Ozogamicin for CD33-Positive AML
On September 1, 2017, the U.S. Food and Drug Administration (FDA) approved gemtuzumab ozogamicin (Mylotarg, Pfizer Inc.) for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and for treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older. Gemtuzumab ozogamicin may be used in combination with daunorubicin and cytarabine for adults with newly-diagnosed AML, or as a stand-alone treatment for certain adult and pediatric patients.
FDA Approves Tisagenlecleucel for B-cell ALL, Tocilizumab for Cytokine Release Syndrome
On August 30, 2017, the U.S. Food and Drug Administration granted regular approval to tisagenlecleucel for the treatment of patients up to age 25 years with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse.
FDA Approves Inotuzumab Ozogamicin for Relapsed, Refractory B-Cell Precursor ALL
On Aug. 17, 2017, the U.S. Food and Drug Administration approved inotuzumab ozogamicin for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
FDA Approves Enasidenib for Adults With Relapsed or Refractory AML With an IDH2 Mutation
On August 1, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to enasidenib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
FDA Approves Rituximab Plus Hyaluronidase Combination for Treatment of FL, DLBCL, and CLL
On June 22, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to the combination of rituximab and hyaluronidase human (Rituxan Hycela, Genentech Inc.) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.
Using Patient-Reported Outcomes Improves Symptoms in Adults With Acute Leukemia
Ashley Bryant, PhD, RN, OCN®, assistant professor at the University of North Carolina at Chapel Hill School of Nursing, was the recipient of the 2017 Victoria Mock New Investigator Award and gave a lecture at the 42nd Annual Congress in Denver, CO, on her work on patient-reported symptoms and quality of life.
Study Tracks Stress on Family of Those Diagnosed With AML
Stress associated with an acute myeloid leukemia (AML) diagnosis and its treatment impacts not only patients, but also their family. Limited research is available on the relationship between psychologic symptoms, stress, and family needs following an AML diagnosis.
FDA Approves Midostaurin for FLT3-Positive Adult AML, Advanced Systemic Mastocytosis
On April 28, 2017, the U.S. Food and Drug Administration (FDA) approved midostaurin for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive (FLT3+), as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.