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leukemia

Inotuzumab Ozogamicin for Relapsed/Refractory B-Cell Precursor ALL

On August 17, 2017, inotuzumab ozogamicin (Besponsa) was approved for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1,2  Supporting Efficacy Data  APPROVAL WAS BASED on complete remission rates in the open-label phase III INO-VATE ALL...

leukemia

Positive Results from Phase III MURANO Trial Evaluating Venetoclax in Combination With Rituximab in Relapsed/Refractory CLL

The phase III MURANO study of venetoclax (Venclexta) tablets in combination with rituximab (Rituxan) met its primary endpoint. Results showed that the combination prolonged progression-free survival in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) compared with bendamustine...

leukemia

Combination of Inotuzumab Ozogamicin and Low-Intensity Chemotherapy in Relapsed or Refractory Ph-Negative ALL

In a single-center phase II trial reported in JAMA Oncology, Jabbour et al found that the combination of inotuzumab ozogamicin (Besponsa) and low-intensity chemotherapy produced promising results in patients with relapsed or refractory Philadelphia chromosome (Ph)-negative acute lymphoblastic...

leukemia

Guadecitabine in Treatment-Naive Older Patients With Acute Myeloid Leukemia

The results of a phase II trial have shown high activity of guadecitabine, a next-generation hypomethylating drug, in treatment-naive older patients with acute myeloid leukemia. The findings were reported in The Lancet Oncology by Kantarjian et al. Guadecitabine has a longer half-life and exposure...

leukemia

Expert Point of View: David Maloney, MD, and Kenneth C. Anderson, MD

SIMILAR CELLULAR immunotherapies are currently being developed and tested by other National Cancer Institute–designated cancer centers, including Fred Hutchinson Cancer Research Center.  David Maloney, MD, Medical Director of Cellular Immunotherapy at Fred Hutchinson and Medical Director of the...

leukemia

FDA Approves First CAR T-Cell Therapy for Pediatric, Young Adult Patients With ALL

ON AUGUST 30, 2017, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah) for pediatric and young adult patients up to 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory to initial treatment or in second or later relapse. Tisagenlecleucel ...

leukemia

Midostaurin in FLT3 Mutation–Positive Acute Myeloid Leukemia and Systemic Mastocytosis

ON APRIL 28, 2017, midostaurin (Rydapt) was approved for treatment of adults with newly diagnosed acute myeloid leukemia (AML) who have FLT3 mutation–positive disease, as detected by a U.S. Food and Drug Administration (FDA)-approved test, in combination with standard cytarabine and daunorubicin...

leukemia

FDA Approves Gemtuzumab Ozogamicin for Treatment of Acute Myeloid Leukemia

The U.S. Food and Drug Administration (FDA) today approved gemtuzumab ozogamicin (Mylotarg) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) whose tumors express the CD33 antigen. The drug was also approved for the treatment of patients aged 2 years and older with...

leukemia

FDA Approves First CAR T-Cell Therapy for Pediatric and Young Adult Patients With B-Cell Precursor ALL

Today, the U.S. Food and Drug Administration (FDA) issued what it has called a “historic action,” making the first gene therapy available in the United States. The FDA approved tisagenlecleucel (Kymriah) for certain pediatric and young adult patients with a form of acute lymphoblastic...

hematologic malignancies
leukemia

Early-Phase Study Finds Vitamin C May Activate TET2 Function

Vitamin C may “tell” faulty stem cells in the bone marrow to mature and die normally, instead of multiplying to cause blood cancers. This is the finding of a study led by researchers from Perlmutter Cancer Center at NYU Langone Health, and published by Cimmino et al in Cell....

leukemia

Arsenic Trioxide and Reduced Anthracycline Dose in Pediatric Acute Promyelocytic Leukemia

In the phase III historically controlled Children’s Oncology Group (COG) AAML0631 trial, arsenic trioxide consolidation permitted the use of lower-dose anthracycline without appearing to compromise outcomes in pediatric patients with acute promyelocytic leukemia (APL). The results were...

leukemia

FDA Approves Inotuzumab Ozogamicin for Relapsed or Refractory B-Cell Precursor ALL

On August 17, 2017, the U.S. Food and Drug Administration (FDA) approved inotuzumab ozogamicin (Besponsa) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). INO-VATE ALL The approval was based on data from INO-VATE ALL, a randomized (1:1), ...

leukemia

End-of-Life Care for Older Patients With Acute Myeloid Leukemia

As reported in the Journal of Clinical Oncology by Wang et al, many older patients with acute myeloid leukemia (AML) do not receive hospice care at the end of life, with those who do tending to enroll in hospice within days of death. Study Details The population-based retrospective cohort study...

leukemia

Blinatumomab in Advanced Acute Lymphoblastic Leukemia: A Brighter Therapeutic Outlook

NEW DRUGS that will improve the outcome of adult patients who develop a deadly disease such as acute leukemia are badly needed; combinations of cytotoxic chemotherapeutic drugs may have reached an upper limit of utility. Agents that eradicate leukemia by alternative mechanisms would be of...

leukemia

Improved Overall Survival With Blinatumomab vs Chemotherapy in Advanced Acute Lymphoblastic Leukemia

IN THE PHASE III TOWER TRIAL reported in The New England Journal of Medicine, Hagop Kantarjian, MD, of The University of Texas MD Anderson Cancer Center, and colleagues found that blinatumomab (Blincyto) treatment improved overall survival vs chemotherapy in heavily pretreated patients with B-cell ...

leukemia

FDA Approves Liposome-Encapsulated Combination of Daunorubicin-Cytarabine for Some Types of Poor-Prognosis AML

On August 3, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine (Vyxeos) for the treatment of adults with newly diagnosed therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related...

hematologic malignancies
multiple myeloma
lymphoma
leukemia
myelodysplastic syndromes

Selected Abstracts on Novel Therapies for Hematologic Malignancies

THE 22ND CONGRESS of the European Hematology Association (EHA) was held in June in Madrid, drawing hematologists and allied professionals from every subspecialty of hematology from around the world. Among the extensive educational and scientific program, the EHA Congress provides a forum for...

breast cancer
leukemia
supportive care
gastrointestinal cancer

FDA Actions Yield Extended Approvals of Novel Agents, Advisory Committee Votes Favorably on Two Biosimilars and Pediatric Indication for CAR T-Cell Therapy

DURING JULY, the U.S. Food and Drug Administration (FDA) and its Oncologic Drugs Advisory Committee (ODAC) made a number of approvals and recommendations on a variety of oncology products.  Neratinib  ON JULY 1 7, the FDA approved neratinib (Nerlynx) for the extended adjuvant treatment of adult...

leukemia

FDA Approves Enasidenib in Relapsed or Refractory Acute Myeloid Leukemia

Today, the U.S. Food and Drug Administration (FDA) approved enasidenib (Idhifa) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which ...

leukemia

Asparaginase-Associated Pancreatitis in Childhood Acute Lymphoblastic Leukemia

An observational study reported in The Lancet Oncology by Wolthers et al in the Ponte di Legno Toxicity Working Group identified characteristics and the course of asparaginase-associated pancreatitis in childhood acute lymphoblastic leukemia. Study Details The study involved merged data from...

leukemia

FDA Grants Venetoclax Breakthrough Therapy Designation for Geriatric Patients With Acute Myeloid Leukemia

On July 28, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for venetoclax (Venclexta) in combination with low-dose cytarabine for elderly patients with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. FDA...

leukemia

Response to CAR T-Cell Therapy After Ibrutinib in Chronic Lymphocytic Leukemia

As reported by Turtle et al in the Journal of Clinical Oncology, anti-CD19 chimeric antigen receptor–modified (CAR) T-cell therapy produced high response rates in patients with chronic lymphocytic leukemia previously treated with ibrutinib (Imbruvica). Study Details In the phase I/II study, ...

leukemia

Ongoing Research in Cancer Immunotherapy for Children With Leukemia

THE CANCER IMMUNOTHERAPY PROGRAM at Children’s Hospital of Philadelphia has several clinical trials of chimeric antigen receptor (CAR) T-cell therapy available to eligible patients.  Pilot Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRζ and 4-1BB Signaling...

leukemia

Pivotal CAR T-Cell Data Reported in Relapsed/Refractory B-Cell ALL

UPDATED RESULTS from the ELIANA clinical trial of CTL019 (tisagenlecleucel)—an investigational chimeric antigen receptor (CAR) T-cell therapy—found that remission rates are maintained at 6 months in relapsed/refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia....

leukemia

Effect of Methotrexate and Corticosteroid Strategies on Neurocognitive Function in Patients With B-Lineage ALL

In a Children’s Oncology Group (COG) study (AALL06N1) reported in the Journal of Clinical Oncology, Hardy et al found that age < 10 years at diagnosis was associated with poorer neurocognitive function in patients with high-risk B-lineage acute lymphoblastic leukemia regardless of...

leukemia

CD33 Splicing Polymorphism and Response to Gemtuzumab Ozogamicin in AML

In an analysis of the phase III Children’s Oncology Group AAML0531 trial, published by Lambda et al in the Journal of Clinical Oncology, the CD33-targeted immunoconjugate gemtuzumab ozogamicin was shown to have benefit among patients with de novo acute myeloid leukemia (AML) who carry the CC...

leukemia

FDA’s Advisory Committee Supports CTL019 in Pediatric, Young Adult Patients With B-Cell ALL

Today, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) met to discuss the biologics license application (BLA) for the chimeric antigen receptor (CAR) T-cell therapy CTL019 (tisagenlecleucel) for the treatment of relapsed or refractory pediatric and young adult...

leukemia

Blinatumomab Granted Full Approval to Treat Relapsed or Refractory B-cell Precursor ALL in Adults and Children

On July 11, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for blinatumomab (Blincyto) to include overall survival data from the phase III TOWER study. The approval converts blinatumomab's accelerated approval to a full approval. The sBLA...

leukemia

FDA Accepts sNDA for Dasatinib in Pediatric Patients With Philadelphia Chromosome–Positive Chronic-Phase CML

On July 10, the U.S. Food and Drug Administration (FDA) accepted a supplemental new drug application (sNDA) to include an indication for dasatinib (Sprycel) to treat children with Philadelphia chromosome–positive chronic-phase chronic myeloid leukemia (CML), as well as a powder for oral...

leukemia

Idarubicin vs High-Dose Daunorubicin Induction in Newly Diagnosed Acute Myeloid Leukemia

A Korean phase III trial has shown no difference in outcomes with high-dose daunorubicin vs idarubicin induction in newly diagnosed acute myeloid leukemia, although high-dose daunorubicin was associated with better outcomes in patients with FLT3–internal tandem duplication (ITD) mutation....

leukemia

Blinatumomab in B-Precursor Acute Lymphoblastic Leukemia

In a phase II trial reported in the Journal of Clinical Oncology, Giovanni Martinelli, MD, of S. Orsola University Hospital, Bologna, and colleagues found that blinatumomab (Blincyto) produced complete responses in patients with relapsed/refractory Philadelphia chromosome–positive B-precursor...

leukemia

Expert Point of View: Nitin Jain, MD, and Susan O'Brien, MD

Formal discussant of the GENUINE trial, Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center, Houston, noted that the majority of responses to ibrutinib (Imbruvica) in high-risk patients are partial responses. “These patients [have disease progression] even in the context of...

leukemia

Ublituximab/Ibrutinib Beneficial in Patients With Chronic Lymphocytic Leukemia

The addition of ublituximab (a glycoengineered anti-CD20 antibody) to ibrutinib (Imbruvica) improved response rates, depth of response, and led to quicker resolution of ibrutinib-associated lymphocytosis in patients with high-risk chronic lymphocytic leukemia (CLL) in the phase III GENUINE trial,...

leukemia

Phase III CASCADE Trial of Vadastuximab Talirine in Front-Line AML Discontinued

On June 22, 2017, Seattle Genetics confirmed it discontinued the phase III CASCADE clinical trial of vadastuximab talirine (SGN-CD33A) in front-line older acute myeloid leukemia (AML) patients. Patient enrollment and treatment in all of its vadastuximab talirine clinical trials are suspended,...

leukemia

Idelalisib in Resistant CLL: Benefit Shown, Questions Remain

As reported in The Lancet Oncology by Dr. Andrew Zelenetz and colleagues and reviewed in this issue of The ASCO Post, an international phase III trial in 416 patients with refractory or recurrent chronic lymphocytic leukemia (CLL) addressed the benefit of adding the first-in-class phosphoinositide...

leukemia

Adding Idelalisib to Bendamustine/Rituximab in Relapsed/Refractory CLL

As reported by Andrew D. Zelenetz, MD, of Memorial Sloan Kettering Cancer Center, and colleagues in The Lancet Oncology, interim analysis of a phase III trial has shown the superiority of adding the phosphoinositide-3-kinase δ inhibitor idelalisib (Zydelig) to bendamustine/rituximab (Rituxan) in...

leukemia

Adding Midostaurin to Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia With FLT3 Mutation

In a phase III trial (Cancer and Leukemia Group B 10603 [RATIFY]/Alliance) reported in The New England Journal of Medicine, Stone et al found that the addition of midostaurin (Rydapt) to standard chemotherapy improved overall survival in patients with newly diagnosed acute myeloid leukemia with...

hematologic malignancies
leukemia
lymphoma
myelodysplastic syndromes

FDA Allows Marketing of Test to Aid in the Detection of Certain Leukemias and Lymphomas

On June 29, the U.S. Food and Drug Administration (FDA) allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency-authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin...

leukemia

EHA 2017: Half of Chronic-Phase Philadelphia Chromosome–Positive CML Patients Stay in Treatment-Free Remission 2 Years After Stopping Nilotinib

New data from two clinical trials—ENESTfreedom and ENESTop—demonstrates that approximately half of adult patients with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in the chronic phase, were able to maintain treatment-free remission after stopping treatment with ...

leukemia

EHA 2017: Updated CTL019 ELIANA Data Show Durable Remission Rates in Children, Young Adults With Relapsed/Refractory B-Cell ALL

Updated results from the ELIANA clinical trial demonstrated CTL019 (tisagenlecleucel) remission rates are maintained at 6 months in relapsed/refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). These data from this pivotal trial of CTL019 show that 83% (52...

leukemia
lymphoma

FDA Approves Rituximab Plus Hyaluronidase Combination for Treatment of Certain Hematologic Malignancies

On June 22, 2017, the U.S. Food and Drug Administration granted regular approval to the combination of rituximab and hyaluronidase human (Rituxan Hycela) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. The approval provides a...

leukemia

Phase III CASCADE Trial of Front-Line Vadastuximab Talirine in AML Discontinued

Seattle Genetics has discontinued its phase III CASCADE clinical trial of front-line vadastuximab talirine (SGN-CD33A) in older acute myeloid leukemia (AML) patients. The phase III CASCADE clinical trial is a randomized, double-blind, placebo-controlled study evaluating vadastuximab talirine...

leukemia

Expert Point of View: Susan O'Brien, MD

Commenting on the studies of CAR T cells in chronic lymphocytic leukemia (CLL) thus far, Susan O’Brien, MD, of the University of California at Irvine, said: “Some people are disappointed in the results, but the problem is there was too much hype to begin with. The first article on CAR T published...

leukemia

Newer Approaches With CAR T Cells Explored in CLL

Chimeric antigen receptor (CAR) T-cell therapy is a hot area of research and development in hematologic malignancies and, more recently, some solid tumors. Results have been particularly good in acute lymphocytic leukemia, and one or more CAR T-cell products may be getting close to approval by the ...

leukemia

Using a Pediatric Treatment Approach to Improve Outcomes for Young Adults With ALL

Three years ago, early results from the U.S. Intergroup C10403 trial,1 which evaluated the effectiveness of treating adolescent and young adults (AYAs) with acute lymphoblastic leukemia (ALL) using an intensive pediatric regimen, showed significant improvement in event-free and overall survival...

leukemia

ICML 2017: Phase III GENUINE Trial: Ublituximab Plus Ibrutinib in High-Risk CLL

Data was recently presented from the phase III GENUINE trial of ublituximab, a novel glycoengineered anti–CD20 monoclonal antibody, in combination with ibrutinib (Imbruvica), a Bruton tyrosine kinase (BTK) inhibitor, for the treatment of high-risk chronic lymphocytic leukemia (CLL), at the...

leukemia
lymphoma

ICML 2017: Triplet Combination of Umbralisib, Ublituximab, and Ibrutinib in CLL/SLL/NHL

Data from the chemotherapy-free triple combination of umbralisib, an oral, next generation PI3K delta inhibitor; ublituximab, a novel glycoengineered anti-CD20 monoclonal antibody; and ibrutinib (Imbruvica) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and...

leukemia

Clofarabine-Based Consolidation in Younger Patients With AML

In a French randomized phase II trial reported in the Journal of Clinical Oncology, Thomas et al found that clofarabine-based consolidation may provide improved relapse-free survival vs conventional high-dose cytarabine in postremission treatment in younger patients with acute myeloid leukemia...

hematologic malignancies
leukemia

Idelalisib Toxicities Appear to Be Immune-Related

Phosphoinositide 3-kinase (PI3K) inhibitors represent a highly active class of drug for the treatment of chronic lymphocytic leukemia (CLL). Idelalisib (Zydelig), a PI3K-delta inhibitor and the first PI3K inhibitor to be approved by the U.S. Food and Drug Administration (FDA) for CLL, has...

leukemia

Venetoclax Achieves Durable and Deep Remissions in CLL

Preliminary study results suggest that venetoclax (Venclexta) plus rituximab (Rituxan) is a highly active combination in relapsed/refractory chronic lymphocytic leukemia (CLL), achieving durable responses and minimal residual disease negativity in previously treated patients. “The results of our...

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