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leukemia
immunotherapy

Jeff P. Sharman, MD, on CLL: Trial Results on Acalabrutinib, Obinutuzumab, and Chlorambucil

Jeff P. Sharman, MD, of the Willamette Valley Cancer Institute and US Oncology Research, discusses phase III findings from the ELEVATE TN study, which showed that acalabrutinib plus obinutuzumab and acalabrutinib monotherapy improved progression-free survival in patients with treatment-naive...

leukemia
immunotherapy

Patrick A. Brown, MD, on B-Cell ALL in Children, Adolescents, and Young Adults: Blinatumomab vs Chemotherapy

Patrick A. Brown, MD, of Johns Hopkins University, discusses phase III findings from a Children’s Oncology Group Study showing that blinatumomab was superior to chemotherapy in terms of efficacy and tolerability for young patients as a post-reinduction therapy in the setting of high- and...

leukemia
myelodysplastic syndromes
genomics/genetics

Ilaria Iacobucci, PhD, on AML and MDS: Moving Beyond Gene Panel–Based Classifications

Ilaria Iacobucci, PhD, of St. Jude Children’s Research Hospital, discusses her work to more accurately define mutation subtypes in acute myeloid leukemia and myelodysplastic syndromes, as well as the implications for diagnosis, prognosis, and treatment (Abstract LBA-4 ).

leukemia

Jerald P. Radich, MD, on CML: Predicting Deep Molecular Response to Treatment

Jerald P. Radich, MD, of the Fred Hutchinson Cancer Research Center, discusses a gene-expression model that distinguishes patients with chronic myeloid leukemia who achieved a deep molecular response from those with a poor response to treatment. This work could yield new therapeutic targets that...

leukemia

Andrew H. Wei, MBBS, PhD, on AML: Results From the QUAZAR Trial on Oral Azacitidine

Andrew H. Wei, MBBS, PhD, of The Alfred Hospital, Melbourne, discusses phase III findings on oral azacitidine (CC-486), the first treatment used in the maintenance setting shown to improve both overall and disease-free survival in patients with acute myeloid leukemia that is in remission following...

leukemia
lymphoma

Jennifer Crombie, MD, on Relapsed or Refractory CLL/SLL: Results From a Phase I Trial of Duvelisib and Venetoclax

Jennifer Crombie, MD, of Dana-Farber Cancer Institute, discusses early study results which showed that duvelisib plus venetoclax showed activity in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, with no dose-limiting toxicities observed (Abstract 1763).

leukemia

Tait D. Shanafelt, MD, on CLL in Younger Patients: Comparing Ibrutinib and Rituximab With FCR

Tait D. Shanafelt, MD, of Stanford University, discusses extended follow-up data that show ibrutinib plus rituximab improved clinical outcomes vs the standard therapy of fludarabine/cyclophosphamide/ rituximab in younger patients with previously untreated chronic lymphocytic leukemia (Abstract 33).

leukemia

Mhairi Copland, PhD, MB BChir, on Blast Phase CML: A Possible Treatment Advance

Mhairi Copland, PhD, MB BChir, of the University of Glasgow, discusses results of a study on the combination of ponatinib and fludarabine, cytarabine, idarubicin, and G-CSF for patients with blast phase chronic myeloid leukemia, a rare complication with a poor outcome (Abstract 497).

leukemia

Nitin Jain, MD, on First-Line Ibrutinib Plus Venetoclax in CLL

Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center, discusses findings from two studies showing that the combination of ibrutinib and venetoclax is an effective chemotherapy-free oral regimen for patients with high-risk, previously untreated chronic lymphocytic leukemia (Abstract...

myelodysplastic syndromes
leukemia

Mikkael A. Sekeres, MD, on Newly Diagnosed Hematologic Malignancies: Early Trial Findings on Glasdegib Plus Azacitidine

Mikkael A. Sekeres, MD, of the Cleveland Clinic, discusses results of a phase Ib study of glasdegib in combination with azacitidine, which showed activity in patients with untreated myelodysplastic syndromes, acute myeloid leukemia, and chronic myelomonocytic leukemia who are ineligible for...

leukemia
immunotherapy

Nitin Jain, MD, on CLL: Is There a Role for Chemoimmunotherapy?

Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center, discusses the debate on evolving strategies in first-line treatment of CLL.

leukemia
immunotherapy

William G. Wierda, MD, PhD, on Evolving Strategies for First-Line Treatment of CLL

William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, offers commentary on the debate about evolving strategies in first-line chronic lymphocytic leukemia, the clinical trials on such agents as ibrutinib, BTK inhibitors, and venetoclax, and the interest in...

leukemia
prostate cancer
gastrointestinal cancer

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...

leukemia
lung cancer
sarcoma
immunotherapy

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...

leukemia
lymphoma

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....

leukemia
immunotherapy

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 ...

leukemia

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)...

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

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 ...

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...

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...

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 ...

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

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...

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...

breast cancer
gynecologic cancers
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 ...

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

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

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...

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

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...

leukemia

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...

breast cancer
solid tumors
leukemia
lung cancer
lymphoma
multiple myeloma
issues in oncology
immunotherapy

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...

leukemia

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...

leukemia
immunotherapy

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...

leukemia

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).

leukemia

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).

leukemia
immunotherapy

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).

leukemia
lymphoma
immunotherapy

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 ...

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