SOHO 2019: Asciminib/Imatinib in Patients With Previously Treated CML
In a phase I trial, the combination of the BCR-ABL1 inhibitor asciminib and the small-molecule kinase inhibitor imatinib showed preliminary efficacy, safety, and tolerability in patients with chronic myeloid leukemia (CML) resistant to or intolerant of treatment with two or more prior tyrosine...
Having Cancer as a Teenager Derailed My Life Course
In 1994, I was a normal, active 15-year-old, who loved cars, sports, and rock music, especially songs from my favorite group, The Clash. In fact, it was while jubilantly dancing alone in my room to one of their tunes that I vomited into my hands, an early symptom of acute myeloid leukemia (AML). I...
FDA Pipeline: Fast Track Designation in Myelodysplastic Syndrome and AML, Plus Multiple Breakthrough Designations
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to magrolimab in myelodysplastic syndrome and acute myeloid leukemia (AML). The agency also granted Breakthrough Therapy designations in lung cancer and desmoid tumors, as well as Breakthrough Device designations...
Risk of Infections in Survivors of Childhood Leukemia
In a study reported in the Journal of Clinical Oncology, Pelland-Marcotte et al found that survivors of childhood leukemia remained at significantly increased risk of infection compared with matched controls during an extended period following completion of treatment. Study Details The...
Chromosomal Abnormalities and Prognosis in NPM1-Mutant AML
In a study reported in the Journal of Clinical Oncology, Angenendt et al found that adverse-risk cytogenetics were associated with significantly poorer outcomes vs normal karyotype among patients with acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation. As stated by the...
FDA Pipeline: Designation in CLL, New Drug Application in GIST, New Prostate Ablation System Receives 510(k) Clearance
Recently, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to acalabrutinib in chronic lymphocytic leukemia (CLL), accepted a new drug application for avapritinib in some types of gastrointestinal stromal tumors (GIST), and granted 501(k) clearance to market the...
Ibrutinib/Rituximab vs Standard Chemoimmunotherapy in Previously Untreated CLL
In an interim analysis of the phase III E1912 trial reported in The New England Journal of Medicine, Shanafelt et al found that ibrutinib/rituximab improved progression-free and overall survival vs standard chemoimmunotherapy in patients 70 years old or younger with previously untreated chronic...
FDA Pipeline: Label Update for Durvalumab in NSCLC; Applications Accepted in Epithelioid Sarcoma, AML
Recently, the U.S. Food and Drug Administration (FDA) approved the inclusion of overall survival from the PACIFIC trial in the U.S. prescribing information for durvalumab and accepted applications for a new drug in the treatment of epithelioid sarcoma and two orphan drugs in the treatment of acute...
Active Regimen for High-Risk and Older Patients With Previously Untreated Chronic Lymphocytic Leukemia
In a single-center phase II trial reported in The New England Journal of Medicine, Nitin Jain, MD, and colleagues found that the combination of ibrutinib and venetoclax was highly active in previously untreated high-risk and older patients with chronic lymphocytic leukemia (CLL). In the study, 80 ...
FDA Approves Rituximab Biosimilar for Non-Hodgkin Lymphoma, CLL, and Autoimmune Conditions
Today, the U.S. Food and Drug Administration (FDA) approved rituximab-pvvr (Ruxience), a biosimilar to rituximab (Rituxan), for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis and microscopic polyangiitis....
CLARITY: Ibrutinib Plus Venetoclax in Relapsed or Refractory Chronic Lymphocytic Leukemia
In the phase II CLARITY trial reported in the Journal of Clinical Oncology, Hillmen et al found that the combination of ibrutinib and venetoclax resulted in high rates of minimal residual disease eradication in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). In the...
Anesthesia Exposure and Neurocognitive and Neuroimaging Outcomes in Long-Term Survivors of Childhood ALL
In a study reported in JAMA Oncology, Banerjee et al found that higher cumulative anesthesia exposure and duration of exposure during treatment of childhood acute lymphoblastic leukemia (ALL) may be associated with adverse neurocognitive and abnormal neuroimaging outcomes in long-term survivors....
Substitution of Clofarabine for Anthracycline/Etoposide in Induction Therapy for Pediatric Acute Myeloid Leukemia
In the phase III AML08 trial reported in the Journal of Clinical Oncology, Rubnitz et al found that the use of clofarabine instead of an anthracycline and etoposide in the first course of induction therapy may be a feasible strategy in pediatric patients with acute myeloid leukemia. The trial,...
FDA Approves First-Line Ivosidenib for IDH1-Mutated AML
On May 2, the U.S. Food and Drug Administration (FDA) expanded its approval of ivosidenib (Tibsovo) to include newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that ...
Fixed-Duration Venetoclax Plus Obinutuzumab as First-Line Treatment in Older Patients With CLL Who Have Comorbidities
A fixed-duration regimen of venetoclax plus obinutuzumab demonstrated superior progression-free survival, complete response rates, and minimal residual disease (MRD) negativity compared with chlorambucil plus obinutuzumab as first-line therapy for older patients with chronic lymphocytic leukemia...
New NCCN Guidelines for Pediatric Acute Lymphoblastic Leukemia
Recently, the National Comprehensive Cancer Network® (NCCN®) debuted the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pediatric Acute Lymphoblastic Leukemia (ALL)—the most comprehensive and up-to-date, evidence-based, consensus-driven guidelines for treating children with...
Association of Antibodies With Pegaspargase Allergic Reactions and Failure of Rechallenge in Pediatric ALL
In a study reported in the Journal of Clinical Oncology, Liu et al determined the frequency of allergic reactions and consequences of development of antibodies to pegaspargase (PEG-ASP) among pediatric patients with newly diagnosed acute lymphoblastic leukemia (ALL). As noted by the...
EHA 2019: ASCEND Trial Compares Acalabrutinib vs Investigator’s Choice in Relapsed or Refractory CLL
The randomized, global, multicenter, open-label phase III ASCEND trial evaluated the efficacy and safety of acalabrutinib vs investigator’s choice of rituximab/idelalisib or rituximab/bendamustine in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Ghia et al presented ...
EHA 2019: CLL12 Trial Investigates Ibrutinib in Previously Untreated, Asymptomatic Early-Stage CLL
At the 24th Annual Congress of the European Hematology Association (EHA), Langerbeins et al presented findings from the phase III CLL12 trial, which evaluated whether ibrutinib prolongs event-free survival in patients with previously untreated, Binet stage A chronic lymphocytic leukemia (CLL)...
QuANTUM-R: Quizartinib vs Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD–Positive AML
In the phase III QuANTUM-R trial reported in The Lancet Oncology, Cortes et al found that the FLT3 inhibitor quizartinib produced a modest but significant improvement in overall survival vs salvage chemotherapy in relapsed or refractory FLT3 internal tandem duplication (FLT3-ITD)-positive acute...
François-Xavier Mahon, MD, PhD, on Chronic-Phase Chronic Myeloid Leukemia: Treatment-Free Remission After Second-Line Treatment
François-Xavier Mahon, MD, PhD, of the Université Bordeaux and Institut Bergonie, discusses results of the ENESTop study, which demonstrated the long-term durability and safety of treatment-free remission in chronic-phase CML after second-line nilotinib (Abstract 7005).
2019 ASCO: CLL14 Trial Evaluates First-Line Venetoclax/Obinutuzumab in Previously Untreated CLL
The phase III CLL14 trial—reported by Fischer et al at the 2019 ASCO Annual Meeting (Abstract 7502) and in The New England Journal of Medicine—found that the BCL2 inhibitor venetoclax plus the monoclonal antibody obinutuzumab prolonged progression-free survival vs obinutuzumab and...
First-Line Ibrutinib and Venetoclax for High-Risk and Older Patients With Previously Untreated CLL
In a single-center phase II trial reported in The New England Journal of Medicine, Jain et al found that the combination of ibrutinib and venetoclax was highly active in previously untreated high-risk and older patients with chronic lymphocytic leukemia (CLL). In the study, 80 patients...
Kerry A. Rogers, MD, on Chronic Lymphocytic Leukemia: Acalabrutinib With Obinutuzumab in Treatment-Naive and Relapsed or Refractory Disease
Kerry A. Rogers, MD, of The Ohio State University, discusses a 3-year follow-up of phase Ib safety and efficacy findings with the selective BTK inhibitor acalabrutinib and the anti-CD20 monoclonal antibody obinutuzumab in patients with CLL (Abstract 7500).
William G. Wierda, MD, PhD, on Immunotherapy for Relapsed/Refractory CLL/SLL: Results From TRANSCEND CLL 004
William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, discusses the TRANSCEND CLL 004 trial, which studied the use of an experimental CD19-directed CAR T-cell product in heavily pretreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (Abstract 7501).
Mark J. Levis, MD, PhD, on Acute Myeloid Leukemia: Gilteritinib in FLT3-Mutated Disease
Mark J. Levis, MD, PhD, of The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, discusses the effect of gilteritinib on survival in patients with FLT3-mutated relapsed/refractory AML who have common co-mutations or a high FLT3-ITD allelic ratio, and the importance of FLT3-ITD testing at diagnosis and again at relapse (Abstract 7000).
FDA Approves Addition of Survival Data to Gilteritinib Label for Refractory FLT3-Mutated AML
On May 29, the U.S. Food and Drug Administration (FDA) approved the addition of overall survival data in the labeling for gilteritinib (Xospata), which is indicated for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation as detected by an FDA-approved...
FDA Approves Chemotherapy-Free Regimen, Venetoclax Plus Obinutuzumab, as First-Line Treatment for CLL/SLL
On May 15, the U.S. Food and Drug Administration (FDA) approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Approval was based on the CLL14...
FDA Approves First-Line Ivosidenib for IDH1-Mutated AML
On May 2, the U.S. Food and Drug Administration (FDA) expanded its approval of ivosidenib (Tibsovo) to include newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that ...
NCCN Clinical Practice Guidelines in Oncology: 2019 Updates
In 1996, the National Comprehensive Cancer Network® (NCCN®) published its first set of Clinical Practice Guidelines in Oncology (NCCN Guidelines®), covering eight tumor types. NCCN Guidelines are now published for more than 70 tumor types and topics. Some of the key updates for 2019 were presented...
FDA Pipeline: Designations in Myeloma, Adenoid Cystic Carcinoma, and Kaposi Sarcoma, Plus ODAC Votes
This week, the U.S. Food and Drug Administration granted designations in relapsed or refractory multiple myeloma, adenoid cystic carcinoma, and Kaposi sarcoma; and the FDA’s Oncologic Drugs Advisory Committee (ODAC) held votes on treatments for tenosynovial giant cell tumor and acute...
FDA Approves Chemotherapy-Free Regimen, Venetoclax Plus Obinutuzumab, as First-Line Treatment for CLL/SLL
The U.S. Food and Drug Administration (FDA) has approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The approval is based on the results of the...
FDA Pipeline: Applications and Designations in Prostate Cancer, Leukemia, and HER2-Positive Cancers
In the past 2 weeks, the U.S. Food and Drug Administration (FDA) accepted a new drug application and granted Priority Review for a prostate cancer treatment, granted Orphan Drug designation to a treatment for acute lymphoblastic leukemia, accepted an investigational new drug application for a...
FDA Approves First-Line Ivosidenib for IDH1-Mutated AML
On May 2, the U.S. Food and Drug Administration (FDA) expanded its approval of ivosidenib (Tibsovo) to include newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that ...
Long-Term Follow-up: Addition of Idelalisib to Rituximab in Relapsed Chronic Lymphocytic Leukemia
In an article published in the Journal of Clinical Oncology, Sharman et al provided long-term findings of a phase III trial that examined the addition of idelalisib to rituximab in relapsed chronic lymphocytic leukemia (CLL), including findings from an extension phase of idelalisib monotherapy. The ...
Intermittent vs Intensive PEG-Asparaginase in Pediatric Acute Lymphoblastic Leukemia
In a Scandinavian study reported in the Journal of Clinical Oncology, Albertsen et al found that use of intermittent vs intensive pegylated (PEG)-asparaginase was associated with similar efficacy and reduced asparaginase-related toxicity in pediatric acute lymphoblastic leukemia (ALL). The study...
Tale of Two FLT3 Inhibitors in AML: Gilteritinib and Quizartinib
Data supporting the use of FLT3 inhibitors in patients with acute myeloid leukemia (AML) were featured at the 2018 ASH Annual Meeting & Exposition. Gilteritinib was evaluated in combination with induction and consolidation as front-line therapy in newly diagnosed patients with AML,1 and...
Phase III Data Support Use of Gilteritinib in Relapsed or Refractory FLT3-Mutated AML
Treatment with gilteritinib, an oral type 1, FLT inhibitor, significantly improved overall survival compared with chemotherapy in patients with FLT3-positive relapsed or refractory acute myeloid leukemia (AML), according to the final results of the phase III ADMIRAL trial.1 The longest survival for ...
FDA Pipeline: Designations for Myelodysplastic Syndromes, Triple-Negative Breast Cancer, AML, and EBV-Associated Cancers
Over the past week, the U.S. Food and Drug Administration (FDA) granted several Fast Track and Orphan Drug designations to treatments for myelodysplastic syndromes, triple-negative breast cancer, acute myeloid leukemia (AML), and Epstein-Barr virus (EBV)-associated cancers. Fast Track Designation...
FDA Pipeline: Designations in Glioblastoma, Neurofibromatosis, Multiple Myeloma, and AML
This week, the U.S. Food and Drug Administration (FDA) granted designations for treatments for recurrent glioblastoma, neurofibromatosis type 1 and plexiform neurofibromas, multiple myeloma, and relapsed or refractory FLT3-ITD acute myeloid leukemia (AML). Fast Track Designation for Ad-RTS-hIL-12...
AACR 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 toxicity.
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 for high-risk acute myeloblastic leukemia, and a low incidence of viral reactivation (Abstract 74).
Update on FDA-Approved CAR T-Cell Products
TISAGENLECLEUCEL IS an anti-CD19 chimeric antigen receptor (CAR) T-cell product approved by U.S. Food and Drug Administration to treat selected hematologic malignancies.1,2 To appreciate the clinical trial findings summarized here, from selected abstracts presented at the 2018 American Society of...
