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Showing 201 - 250Activity of Ivosidenib in IDH1-Mutated Relapsed or Refractory Acute Myeloid Leukemia
As reported at the 2018 ASCO Annual Meeting and in The New England Journal of Medicine by DiNardo et al, early-phase testing has shown activity of ivosidenib, an oral small-molecule inhibitor of mutant IDH1, in patients with IDH1-mutated relapsed or refractory acute myeloid leukemia (AML). IDH1...
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...
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...
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)...
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...
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...
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 ...
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).
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).
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).
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).
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).
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....
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...
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...
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 ...
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...
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.
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...
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.
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...
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...
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...
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...
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...
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).
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)...
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...
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...
FDA Grants Accelerated Approval to Bosutinib for Treatment of Newly Diagnosed Philadelphia Chromosome–Positive CML
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bosutinib (Bosulif) for treatment of patients with newly diagnosed chronic-phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML). BFORE Trial Approval was based on data from ...
ASH 2017: Dasatinib Plus Standard Chemotherapy Demonstrates 3-Year Survival Benefit in Pediatric Patients With Philadelphia Chromosome–Positive ALL
At the 59th American Society of Hematology (ASH) Annual Meeting & Exposition, Hunger et al presented data from the phase II CA180-372 study in pediatric patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL) treated with dasatinib (Sprycel) added ...
ASH 2017: MURANO Trial: Venetoclax Found Superior to Standard Chemotherapy When Combined With Rituximab in CLL
In the phase III MURANO trial, treatment with the targeted cancer drug venetoclax (Venclexta) in combination with rituximab (Rituxan) more than doubled the likelihood that patients with chronic lymphocytic leukemia (CLL) would survive for 2 years without cancer progression, compared to treatment...
ASH 2017: People Aged 75 Years and Older Are Underrepresented in Blood Cancer Clinical Trials
In the first comprehensive analysis of clinical trial enrollment among older adults with blood cancers, researchers from the U.S. Food and Drug Administration (FDA) found significant gaps in participation among those aged 75 and older when considered against the incidence of these malignancies in...
John F. Seymour, MBBS, PhD, on CLL: Results From the MURANO Study
John F. Seymour, MBBS, PhD, of the Peter MacCallum Cancer Centre, discusses an interim analysis of venetoclax plus rituximab vs bendamustine plus rituximab in patients with relapsed/refractory chronic lymphocytic leukemia (Abstract LBA-2).
Nitin Jain, MD, on CLL: Results From a Venetoclax/Ibrutinib Trial
Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center, discusses phase II study results on combined venetoclax and ibrutinib for patients with previously untreated high-risk and relapsed/refractory chronic lymphocytic leukemia (Abstract 429).
ASH 2017: CLARITY Trial: Combination Treatment With Two Targeted Agents Shows Promise in Previously Treated CLL
One-third of patients with previously treated chronic lymphocytic leukemia (CLL) had no detectable disease after 6 months of combination therapy with the targeted agents ibrutinib (Imbruvica) and venetoclax (Venclexta), with no increase in the occurrence of tumor-lysis syndrome, a serious treatment ...
ASH 2017: RESONATE-2 Trial: Patient-Reported Outcomes on Ibrutinib Treatment in Patients With CLL
At the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition, the 3-year follow-up data from the RESONATE-2 study (PCYC-1115/1116) were presented. The investigators found that patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)...
Watch for More From ASH 2017
Phase III ASPIRE Trial of Carfilzomib in Relapsed Multiple Myeloma Overall survival results from the phase III ASPIRE trial will be detailed for the first time in an oral presentation by Stewart et al on Monday, December 11. The addition of carfilzomib to lenalidomide and...
Patients With CLL May Be Willing to Trade Treatment Efficacy for Reduced Side Effects
When choosing their preferred treatment, patients with chronic lymphocytic leukemia (CLL) place the highest value on treatments that deliver the longest progression-free survival, but they are willing to swap some drug efficacy for a reduced risk of serious adverse events, according to a study...
Seattle Children’s Opens Trial for Children and Young Adults With Leukemia That Targets CD22 and CD19 Proteins Simultaneously
Seattle Children’s has opened the first chimeric antigen receptor (CAR) T-cell immunotherapy trial in the U.S. for children and young adults with relapsed or refractory CD19- and CD22-positive acute lymphoblastic leukemia (ALL) that will simultaneously attack two targets on cancer cells. With ...
FDA Grants Regular Approval of Dasatinib for Pediatric Philadelphia Chromosome–Positive CML in Chronic Phase
On November 9, the U.S. Food and Drug Administration (FDA) expanded the indication for dasatinib (Sprycel) tablets to include the treatment of children with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase (CP).This approval for dasatinib in pediatric patients...
2017 ASCO Palliative Care: People With Leukemia and Their Oncologists Have Vastly Different Perceptions of Prognosis
A study of 100 people with acute myeloid leukemia (AML) receiving chemotherapy found that patient and physician perceptions of treatment risk and the likelihood of a cure varied widely. Overall, patients tended to overestimate both the risk of dying due to treatment and the likelihood of a cure....
Bruno C. Medeiros, MD, on AML: Targeted Treatment
Bruno C. Medeiros, MD, of Stanford Cancer Institute, discusses emerging novel agents and targeted molecular abnormalities in the management of acute myeloid leukemia.
David G. Maloney, MD, PhD, on ALL: New Therapeutic Agents
David G. Maloney, MD, PhD, of the Fred Hutchinson Cancer Research Center, reviews the clinical data and ongoing trials evaluating immunotherapy in the setting of relapsed or refractory acute lymphocytic leukemia and discusses major adverse events of treatment.
William G. Wierda, MD, PhD, on CLL: How to Sequence Therapy
William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, discusses sequencing therapy in patients with relapsed/refractory CLL/SLL based on prior treatment and the presence of cytogenetic abnormalities.
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...
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...
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...
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....
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), ...
