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leukemia

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).

leukemia
immunotherapy

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...

leukemia

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...

leukemia

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).  

leukemia
lymphoma
immunotherapy

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).

leukemia

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).

leukemia

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...

Hematologic Malignancies
Leukemia
Lymphoma

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...

Hematologic Malignancies
Leukemia

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 ...

Immunotherapy
Breast Cancer
Lung Cancer
Prostate Cancer
Kidney Cancer
Bladder Cancer
Colorectal Cancer
Pancreatic Cancer
Sarcoma
Leukemia
Skin Cancer
Head and Neck Cancer

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...

cns cancers
solid tumors
leukemia
multiple myeloma
sarcoma

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...

leukemia
lymphoma

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...

solid tumors
leukemia
prostate cancer
pain management

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...

leukemia

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 ...

leukemia

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 ...

leukemia

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...

Leukemia

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...

Hematologic Malignancies
Leukemia

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 ...

breast cancer
leukemia
myelodysplastic syndromes

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...

cns cancers
leukemia
multiple myeloma

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...

leukemia

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 ...

breast cancer
leukemia
myelodysplastic syndromes

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...

leukemia

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...

leukemia

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.

immunotherapy
leukemia
lymphoma

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.

breast cancer
leukemia
multiple myeloma
issues in oncology

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...

leukemia

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...

breast cancer
gynecologic cancer
hematologic malignancies
leukemia
lymphoma
symptom management

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...

leukemia
immunotherapy

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).

Lymphoma
Leukemia
Immunotherapy

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...

Leukemia
Myelodysplastic Syndromes
Lymphoma
Multiple Myeloma
Immunotherapy

Highlights From the 2018 ASH Annual Meeting & Exposition

TO ADD to our ongoing coverage of the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, we bring readers of The ASCO Post these summaries of an assortment of interesting studies. They focus on novel therapies under investigation in the treatment of acute lymphoblastic...

solid tumors
leukemia
lung cancer
lymphoma

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...

leukemia

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...

Leukemia
Lymphoma

FDA Approves Ibrutinib in Combination With Obinutuzumab in Treatment-Naive CLL/SLL

ON JANUARY 28, 2019, 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...

Leukemia

Data Mount for Venetoclax as Add-on Therapy in Acute Myeloid Leukemia

The benefit of adding venetoclax to a hypomethylating agent or low-dose cytarabine in the front-line treatment of acute myeloid leukemia (AML) was evident from a number of studies reported at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition (see Table 1). For elderly...

leukemia

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...

leukemia
lymphoma

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...

leukemia
myelodysplastic syndromes

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...

Leukemia

Expert Point of View: Elihu H. Estey, MD; Steven Gore, MD; and Mark J. Levis, MD, PhD

ELIHU H. ESTEY, MD, Professor of Medicine at the University of Washington and Director of Acute Myeloid Leukemia (AML) Clinical Research at the Fred Hutchinson Cancer Research Center, Seattle, added that with these “robust” outcomes, future trial patients may “not be eager to wind up in the...

Leukemia

Use of Isocitrate Dehydrogenase Inhibitors in Induction Therapy for Newly Diagnosed AML

IN AN OPEN-LABEL phase I study of 153 patients newly diagnosed with acute myeloid leukemia (AML) and mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2, treatment with standard chemotherapy plus the oral IDH inhibitors ivosidenib and enasidenib led to high response rates and possibly impressive ...

Leukemia

Expert Point of View: Joseph Mikhael, MD

JOSEPH MIKHAEL, MD, press conference moderator where these data were discussed, commented on the BEAT AML trial: “One of the greatest challenges in the concept of personalized medicine is that by the time you determine what is right for a patient [ie, genomic analysis], the horse is out of the...

Leukemia

BEAT AML Umbrella Trial: Bringing Personalized Medicine to Acute Myeloid Leukemia

THE MULTIARM, multicollaborative BEAT AML umbrella trial demonstrated the feasibility of using next-generation sequencing to assign treatment tailored to individual genomics of elderly patients with acute myeloid leukemia (AML) within 7 days. This may prove to be a major advance, since typically...

leukemia

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...

Hematologic Malignancies
Leukemia

Remnants of Cancer Remain, but Demons Are Now Gone

In the summer of 2002, I was a physically active 17-year-old boy on the cusp of adulthood. I was about to enter my senior year in high school, and like other teens my age, I was excited about college and the promise of the undreamed-of opportunities that lay ahead. At first, the lethargy I was...

leukemia
myelodysplastic syndromes

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. ...

leukemia

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...

Leukemia

Priority Review for Quizartinib in Relapsed or Refractory FLT3-ITD–Positive AML

THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) accepted a new drug application and granted Priority Review to quizartinib, a FLT3 inhibitor, for the treatment of adult patients with relapsed or refractory FLT3-ITD–positive acute myeloid leukemia (AML). The FDA is expected to make a decision on...

Hematologic Malignancies
Leukemia

Venetoclax in Combination Regimens for Older Patients With AML or Those With Comorbidities Precluding Intensive Induction

On November 21, 2018, venetoclax (Venclexta) was granted accelerated approval for use in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients aged ≥ 75 years or who have comorbidities that preclude the use of ...

leukemia

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...

Hematologic Malignancies
Leukemia

Fixed-Duration Venetoclax Plus Rituximab in Relapsed or Refractory CLL

In patients with relapsed or refractory chronic lymphocytic leukemia (CLL), fixed-duration venetoclax -(Venclexta) combined with rituximab (Rituxan) reduced the risk of disease progression or death compared with standard-of-care bendamustine/rituximab, according to longer-term follow-up of the...

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