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leukemia
immunotherapy

ASH 2018: ELIANA Trial: Tisagenlecleucel in Pediatric and Young Adult Patients With ALL

A single infusion of tisagenlecleucel (Kymriah) in pediatric and young adult patients with relapsed or treatment-resistant acute lymphocytic leukemia (ALL) continues to be highly effective in most patients, without the need for additional therapies. This latest analysis of the ELIANA trial results...

leukemia

ASH 2018: Ibrutinib Alone or in Combination With Rituximab vs Bendamustine Plus Rituximab in Older Patients With CLL

A new study presented by Woyach et al at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 6) showed that older patients with chronic lymphocytic leukemia (CLL) have a significantly lower rate of disease progression if treated with ibrutinib rather than...

leukemia
immunotherapy

ASH 2018: Azacitidine With Nivolumab Plus Ipilimumab vs Azacitidine Plus Nivolumab in Relapsed or Refractory AML

A triplet therapy combining two immune checkpoint inhibitors with the standard of care azacitidine has shown promising results for treatment of relapsed or refractory acute myeloid leukemia (AML), according to the findings of a phase II study conducted at The University of Texas...

leukemia

FDA Approves Gilteritinib for Relapsed or Refractory FLT3-Mutated AML

Today, the U.S. Food and Drug Administration (FDA) approved gilteritinib (Xospata) for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. The FDA also approved an expanded indication for a companion ...

leukemia

FDA Approves Venetoclax Combination for Adults With AML

On November 21, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to venetoclax (Venclexta) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older or...

leukemia

FDA Approves Glasdegib for Patients With Newly Diagnosed AML Who Cannot Undergo Intensive Chemotherapy

Today, the U.S. Food and Drug Administration (FDA) approved glasdegib (Daurismo) tablets to be used in combination with low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or with comorbidities that may preclude the use of ...

leukemia
immunotherapy

Azacitidine Plus Nivolumab in Relapsed or Refractory AML

A combination of the chemotherapy drug azacitidine with the immune checkpoint inhibitor nivolumab (Opdivo) demonstrated an encouraging response rate and overall survival in patients with relapsed or refractory acute myeloid leukemia (AML), according to findings from a phase II study published...

palliative care
survivorship
myelodysplastic syndromes
leukemia

Suleika Jaouad on Making the Most of a Life Interrupted: A Young Adult Perspective on Cancer

Suleika Jaouad, an Emmy Award–winning writer, advocate, and cancer survivor who was diagnosed at age 22 with myelodysplastic syndrome and acute myeloid leukemia, discusses what she has learned about coping with cancer, learning from it, and growing beyond it.

leukemia
multiple myeloma

FDA Authorizes First Next-Generation Sequencing–Based Test to Detect Minimal Residual Disease in B-Cell ALL or Multiple Myeloma

The U.S. Food and Drug Administration (FDA) recently permitted marketing of the ClonoSEQ assay, a next-generation sequencing–based test for minimal residual disease in patients with B-cell acute lymphoblastic leukemia (ALL) or multiple myeloma. “At the FDA, we’re continuing to...

leukemia

Jerald P. Radich, MD, on Chronic-Phase CML: Optimizing Tyrosine Kinase Inhibitor Therapy

Jerald P. Radich, MD, of the Fred Hutchinson Cancer Research Center, discusses the best strategies for sequencing tyrosine kinase inhibitor therapy for chronic myeloid leukemia and treatment-free remission.

leukemia
lymphoma

FDA Approves Duvelisib for Adult Patients With Relapsed or Refractory CLL, SLL, and Follicular Lymphoma

On September 24, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to duvelisib (Copiktra) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. In addition, duvelisib...

leukemia

Origins and Genetics Associated With Mixed-Phenotype Acute Leukemia

Investigators have unraveled the origins and identified mutations associated with mixed-phenotype acute leukemia. The study, published by Alexander et al in Nature, potentially lays the foundation for more effective treatment of patients with this high-risk cancer. Mixed-phenotype acute...

leukemia

FDA Approves Moxetumomab Pasudotox-tdfk for the Treatment of Hairy Cell Leukemia

The U.S. Food and Drug Administration (FDA) today approved moxetumomab pasudotox-tdfk (Lumoxiti) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with...

leukemia

FDA Accepts sBLA for Dasatinib in Pediatric Patients With Newly Diagnosed Ph-Positive ALL

The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for dasatinib in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia...

leukemia
lymphoma
immunotherapy

CAR T-Cell Therapy in Europe: Differing Decisions on Approval of Two Agents

The European Commission (EC) recently approved the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) in the European Union (EU) for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is...

leukemia

FDA Grants Orphan Drug Designation to ASLAN003 in Acute Myeloid Leukemia

The U.S. Food and Drug Administration (FDA) has granted ASLAN003 Orphan Drug designation as a treatment for acute myeloid leukemia (AML). ASLAN003 is an orally active, potent inhibitor of human dihydroorotate dehydrogenase (DHODH) that has the potential to be a first-in-class drug in AML. The FDA...

leukemia
issues in oncology
immunotherapy

Guidelines for Pediatric CAR T-Cell Therapy Developed

Almost 1 year after the U.S. Food and Drug Administration (FDA) approval of chimeric antigen receptor (CAR) T-cell therapy for children with acute lymphoblastic leukemia (ALL), researchers at The University of Texas MD Anderson Cancer Center and the Pediatric Acute Lung Injury and...

leukemia

FDA Grants Breakthrough Therapy Designation to Quizartinib for Relapsed/Refractory FLT3-ITD AML

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to quizartinib, an investigational FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). Breakthrough Therapy designation is designed to...

leukemia

Phase III ASTRAL-1 Study of Guadecitabine in Patients With Treatment-Naive AML Ineligible to Receive Intensive Induction Chemotherapy

Results were recently announced from the ASTRAL-1 study evaluating the efficacy and safety of guadecitabine in adults with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive induction chemotherapy. The study did not meet its co-primary endpoints: complete...

leukemia

Susan M. O’Brien, MD, on CLL: Sequencing Therapy Options

Susan M. O’Brien, MD, of the University of California, Irvine, discusses three oral agents for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma, and the use of chemotherapy for the disease.

leukemia

FDA Approves Ivosidenib for IDH1-Mutated AML

Today, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (isocitrate dehydrogenase-1 [IDH1]...

leukemia

FDA Grants Priority Review for Glasdegib in Patients With Previously Untreated AML

The U.S. Food and Drug Administration (FDA) recently accepted a new drug application and granted Priority Review designation for glasdegib, an investigational oral smoothened inhibitor being evaluated for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) in...

leukemia

EHA 2018: Single-Agent Quizartinib vs Chemotherapy in Relapsed or Refractory AML

Results from the phase III QuANTUM-R study of single-agent quizartinib in relapsed or refractory acute myeloid leukemia (AML) were presented by Cortes et al at the 23rd Annual Congress of the European Hematology Association (EHA) (Abstract LB2600). Study Findings QuANTUM-R study results showed...

leukemia

EHA 2018: Undetectable MRD Rates With Venetoclax Plus Rituximab in Relapsed or Refractory CLL

Investigational data from a new analysis of undetectable minimal residual disease (MRD) rates from the phase III MURANO trial of venetoclax (Venclexta, a first-in-class oral B-cell lymphoma 2 [BCL2] inhibitor) in combination with rituximab (Rituxan) in patients with relapsed or refractory chronic...

leukemia
immunotherapy

EHA 2018: Obinutuzumab or Rituximab Plus Chlorambucil in CLL

Data from the final analysis of the CLL11 study evaluating obinutuzumab (Gazyva)-based treatment in previously untreated chronic lymphocytic leukemia (CLL) was presented by Goede et al during the Presidential Symposium at the 23rd Annual Congress of the European Hematology Association (EHA)...

leukemia

EHA 2018: Alvocidib in Patients With Relapsed or Refractory MCL-1–Dependent AML

Preliminary data from Zella 201—an ongoing phase II study evaluating the efficacy and safety of alvocidib, a potent cyclin-dependent kinase 9 (CDK9) inhibitor, in combination with cytarabine and mitoxantrone in patients with relapsed or refractory MCL-1–dependent acute myeloid leukemia...

leukemia
lymphoma
immunotherapy

iLLUMINATE Trial of Ibrutinib Plus Obinutuzumab for First-Line Therapy of CLL/SLL Meets Primary Endpoint

The phase III iLLUMINATE (PCYC-1130) trial recently met its primary endpoint of improvement in progression-free survival. The study evaluated ibrutinib (Imbruvica) in combination with obinutuzumab (Gazyva) in patients with previously untreated chronic lymphocytic leukemia or small lymphocytic...

leukemia
lymphoma

FDA Approves Second-Line Venetoclax for CLL or SLL With or Without 17p Deletion

On June 8, 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. MURANO Approval was based ...

leukemia
geriatric oncology

Courtney Denton Dinardo, MD, on AML: Treatment Study Results

Courtney Denton Dinardo, MD, of The University of Texas MD Anderson Cancer Center, discusses findings on the durable response with venetoclax in combination with decitabine or azacitidine in elderly patients with acute myeloid leukemia (Abstract 7010).

leukemia
immunotherapy

Peter Hillmen, MB, ChB, on CLL: Results From the MURANO Trial

Peter Hillmen, MB, ChB, of St James’s University Hospital, discusses phase III study findings on minimal residual disease negativity with venetoclax plus rituximab in relapsed or refractory chronic lymphocytic leukemia (Abstract 7508).

leukemia

William G. Wierda, MD, PhD, and Julie M. Vose, MD, MBA, on CLL: Results From the CAPTIVATE Trial

Julie M. Vose, MD, MBA, of the University of Nebraska Medical Center, and William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, discuss phase II findings on ibrutinib plus venetoclax in first-line treatment of chronic lymphocytic leukemia (Abstract 7502).

leukemia

Rita Elias Assi, MD, on AML and Genomics

Rita Elias Assi, MD, of The University of Texas MD Anderson Cancer Center, discusses the impact of next-generation sequencing on treatment selection in acute myeloid leukemia (Abstract 103).

leukemia

Robert J. Kreitman, MD, on Hairy Cell Leukemia: Results From an International Study

Robert J. Kreitman, MD, of the National Cancer Institute, discusses findings on moxetumomab pasudotox in heavily pretreated patients with relapsed or refractory hairy cell leukemia (Abstract 7004).

leukemia

FDA Grants Priority Review to Gilteritinib for the Treatment of Relapsed or Refractory FLT3 Mutation–Positive AML

The U.S. Food and Drug Administration (FDA) has accepted, with Priority Review, a new drug application (NDA) for gilteritinib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) and a mutation in the FLT3 gene, as detected by an FDA-approved test....

leukemia

Pediatric Centers May Improve Survival for Adolescents and Young Adults With ALL

Adolescents and young adults (AYAs) with acute lymphocytic leukemia (ALL) have a survival advantage if they receive treatment at a pediatric cancer center vs an adult center, according to a study published by Muffly et al in Blood Advances. The findings also suggest that treatment at a center...

leukemia
lymphoma

FDA Accepts New Drug Application, Grants Priority Review for Duvelisib in CLL/SLL and Follicular Lymphoma

On April 9, the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review a new drug application (NDA) for the oral agent duvelisib, a first-in-class, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma. The NDA is seeking full approval for duvelisib in...

leukemia

FDA Accepts BLA for Moxetumomab Pasudotox in Hairy Cell Leukemia

On April 3, the U.S. Food and Drug Administration (FDA) accepted a Biologics License Application (BLA) for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukemia (HCL) who have received at ...

leukemia
immunotherapy

FDA Expands Approval of Blinatumomab for Certain Patients With B-Cell Precursor ALL

The U.S. Food and Drug Administration granted accelerated approval to blinatumomab (Blincyto) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). In patients who have achieved remission after...

leukemia
immunotherapy

Bijal D. Shah, MD, on What ALL Tells Us About CAR T Cells

Bijal D. Shah, MD, of the H. Lee Moffitt Cancer Center, discusses key studies of CAR T-cell therapy in relapsed B-cell ALL and the adverse events that this treatment may cause.

leukemia

FDA Expands Nilotinib Indication to Pediatric Patients With CML

Today, the U.S. Food and Drug Administration (FDA) expanded the indication for nilotinib (Tasigna) to include treatment of first- and second-line pediatric patients 1 year of age or older with Philadelphia chromosome–positive chronic myeloid leukemia in the chronic phase. In the United...

leukemia

Ellin Berman, MD, on CML: Disease Management During Pregnancy

Ellin Berman, MD, of Memorial Sloan Kettering Cancer Center, discusses the effects of TKI therapy on fetal development, its impact on pregnancy outcomes, and how to develop an effective treatment plan.

leukemia

Patients With AML Have Reduced Risk of Early Mortality at NCI-Designated Cancer Centers

Researchers at the University of California (UC), Davis, have shown that patients with acute myeloid leukemia (AML) who received their care at a National Cancer Institute (NCI) cancer center in California had a dramatically reduced risk of early mortality. Using data from the California Cancer...

leukemia

FDA Accepts BLA for Calaspargase Pegol in Acute Lymphoblastic Leukemia

On February 28, Shire announced that the U.S. Food and Drug Administration (FDA) accepted the company’s biologics license application (BLA) for calaspargase pegol (Cal-PEG; SHP663). The investigational-stage compound is being reviewed as a component of a multiagent chemotherapeutic regimen...

leukemia

FDA Accepts NDA, Grants Priority Review for Ivosidenib in Relapsed or Refractory IDH1-Mutated AML

On February 15, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for ivosidenib (AG-120) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation. The NDA was granted Priority Review...

leukemia
immunotherapy

FDA’s Oncologic Drugs Advisory Committee to Review Potential New Use of Blinatumomab

On February 14, Amgen announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the supplemental biologics license application (sBLA) for blinatumomab (Blincyto) for the treatment of patients with minimal residual disease...

leukemia
immunotherapy

Updated Analysis of ELIANA Trial Shows Longer-Term Durable Remissions With Tisagenlecleucel in Children, Young Adults With Relapsed/Refractory ALL

Updated results from the ELIANA clinical trial of tisagenlecleucel (Kymriah), formerly CTL019, in relapsed or refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL) have been published by Maude et al in The New England Journal of Medicine. New data include...

leukemia
immunotherapy

Kristen Fousek, PhD Candidate, on B-Cell ALL: CAR T-Cell Treatment

Kristen Fousek, PhD Candidate at Baylor College of Medicine, discusses her preclinical work on targeting CD19-negative relapsed B-cell acute lymphoblastic leukemia, using CAR T cells that target three antigens simultaneously, a technique that addresses the growing problem of relapse (Abstract 121).

leukemia

Arsenic Trioxide With Tretinoin for First-Line Treatment of Acute Promyelocytic Leukemia Approved by the FDA

On January 15, the U.S. Food and Drug Administration (FDA) approved the use of arsenic trioxide (Trisenox) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17)...

leukemia

FDA Updates Nilotinib Label With Information on Discontinuing Treatment in Certain Patients With Early-Phase CML After Sustained Response

On December 22, the U.S. Food and Drug Administration (FDA) updated the product label for nilotinib (Tasigna) to include information for providers about how to discontinue the drug in certain patients. Nilotinib, first approved by the FDA in 2007, is indicated for the treatment of patients with...

leukemia
lymphoma

ICER Releases Draft Evidence Report on CAR T-Cell Therapy for B-Cell Cancers

On December 19, the Institute for Clinical and Economic Review (ICER) released a Draft Evidence Report assessing the comparative clinical effectiveness and value of tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta). The draft report, along with draft voting...

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