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lymphoma
immunotherapy

ECHELON-2: Brentuximab Vedotin Plus Chemotherapy in CD30-Positive Peripheral T-Cell Lymphoma

As reported by Horwitz et al in The Lancet, the phase III ECHELON-2 trial showed that brentuximab vedotin (Adcetris) plus cyclophosphamide, doxorubicin, and prednisone (CHP) improved progression-free and overall survival vs cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in...

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...

lymphoma
immunotherapy

ASH 2018: CAR.CD30 T-Cell Therapy in Relapsed or Refractory CD30-Positive Lymphomas

At the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, Grover et al presented preliminary results from a clinical study of an investigational cellular immunotherapy for Hodgkin lymphoma and non-Hodgkin lymphoma expressing the CD30 protein marker (Abstract 681). Data...

lymphoma
immunotherapy

ASH 2018: Update of ZUMA-1: Axicabtagene Ciloleucel in DLBCL

A follow-up analysis of patients enrolled in the multicenter ZUMA-1 trial for diffuse large B-cell lymphoma (DLBCL) showed axicabtagene ciloleucel can induce durable responses, yield a median overall survival of more than 2 years, and has a manageable long-term safety profile. Axicabtagene...

lymphoma
immunotherapy

ASH 2018: Updated Analysis of JULIET Trial: Tisagenlecleucel in Relapsed or Refractory DLBCL

In an update to the global JULIET clinical trial, the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) led to long-lasting remissions in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The most recent results from the trial were presented by...

breast cancer
gynecologic cancers
lymphoma
pancreatic cancer
gastroesophageal cancer
bladder cancer
symptom management
gastrointestinal cancer

FDA Pipeline: What’s New in Biosimilars, Drug Reviews, Designations, and More

The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Approval for Pegfilgrastim Biosimilar The FDA recently approved a pegfilgrastim biosimilar, pegfilgrastim-cbqv (Udenyca). The biosimilar has been approved to decrease the incidence...

lymphoma
immunotherapy

Combination of Macrophage Immune Checkpoint Inhibitor and Rituximab in Non-Hodgkin Lymphoma

In a phase Ib study reported in The New England Journal of Medicine, Advani et al found that the combination of rituximab (Rituxan) and the CD47-blocking monoclonal antibody Hu5F9-G4 (or 5F9), a macrophage immune checkpoint inhibitor, was active in patients with non-Hodgkin lymphoma. CD47, which is ...

lymphoma
cost of care

Cost-Effectiveness of First-Line Brentuximab Vedotin Plus Chemotherapy in Hodgkin Lymphoma

In a cost-effectiveness analysis reported in the Journal of Clinical Oncology, Huntington et al found that the cost of brentuximab vedotin (Adcetris) would need to be reduced in order for the combination of the agent with chemotherapy in first-line treatment of stage III or IV Hodgkin lymphoma to...

lymphoma
immunotherapy

Analysis of Prognostic Value of Postinduction PET Response After First-Line Immunochemotherapy for Follicular Lymphoma

In an analysis of the phase III GALLIUM trial reported in The Lancet Oncology, Trotman et al found that end-of-induction fluorodeoxyglucose positron-emission tomography (PET) after first-line immunochemotherapy appeared to better predict treatment outcomes than contrast-enhanced computed tomography ...

leukemia
lymphoma

Duvelisib vs Ofatumumab in Relapsed or Refractory CLL/SLL

As reported in the journal Blood by Flinn et al, the phase III DUO trial has shown significantly prolonged progression-free survival with the phosphoinositide 3-kinase (PI3K)-δ,-γ inhibitor duvelisib (Copiktra) vs ofatumumab (Arzerra) in patients with relapsed or refractory chronic...

lymphoma
skin cancer

Results From ECHELON-2: Brentuximab Vedotin in CD30-Expressing Peripheral T-Cell Lymphoma

The phase III ECHELON-2 clinical trial has met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) with brentuximab vedotin (Adcetris) in combination with CHP (cyclophosphamide, doxorubicin, prednisone) vs CHOP (cyclophosphamide,...

lymphoma
skin cancer

In Vitro and Ex Vivo Activity of Gentian Violet in Cutaneous T-Cell Lymphoma

As reported in JAMA Dermatology, Wu and Wood found that the widely available nonprescription topical antimicrobial agent gentian violet has potent activity against cutaneous T-cell lymphoma (CTCL) in studies in vitro and ex vivo. The study involved high-throughput small molecule screening of 1,710...

lymphoma
issues in oncology

Ovarian Function After Response-Adapted Treatment in Younger Women With Advanced Hodgkin Lymphoma

In a secondary analysis of the UK phase III RATHL trial reported in The Lancet Oncology, Anderson et al found that ovarian function recovery was affected by age and type of response-adapted therapy in women receiving treatment for advanced Hodgkin lymphoma. The analysis included 67 eligible...

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
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...

lymphoma
immunotherapy

FDA Approves Ibrutinib Plus Rituximab for Waldenström’s Macroglobulinemia

The U.S. Food and Drug Administration (FDA) has approved ibrutinib (Imbruvica) plus rituximab (Rituxan) for the treatment of adult patients with Waldenström's macroglobulinemia (WM). With this approval, the ibrutinib prescribing information now includes combination use with rituximab,...

lymphoma
skin cancer

Mogamulizumab vs Vorinostat in Previously Treated Cutaneous T-Cell Lymphoma

As reported by Kim and colleagues in The Lancet Oncology, the phase III MAVORIC trial showed that the anti-C-C chemokine receptor 4 (CCR4) monoclonal antibody mogamulizumab (Poteligeo) significantly improved progression-free survival vs vorinostat (Zolinza) among patients with previously treated...

lymphoma
skin cancer

FDA Approves Mogamulizumab-kpkc for Two Rare Types of Non-Hodgkin Lymphoma

Today, the U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new...

lymphoma
immunotherapy

Outcomes by Chemotherapy Backbone for Obinutuzumab vs Rituximab in Previously Untreated Follicular Lymphoma

In an analysis of the GALLIUM trial reported in the Journal of Clinical Oncology, Hiddemann and colleagues found that obinutuzumab (Gazyva) appeared to provide consistent progression-free survival benefit vs rituximab (Rituxan) in previously untreated follicular lymphoma, irrespective of which...

lymphoma
immunotherapy

EHA 2018: Tisagenlecleucel Demonstrates More Than 1-Year Durability of Response in Adults With Relapsed or Refractory DLBCL

Fourteen-month results from the JULIET clinical trial showed ongoing durable responses are achievable with tisagenlecleucel (Kymriah) when administered to adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This updated analysis was presented by Borchmann et al at ...

lymphoma
immunotherapy

FDA Expands Approval of Pembrolizumab to Include New Lymphoma Indication

Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma or those who have relapsed after two or more prior lines of therapy. KEYNOTE-170...

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
immunotherapy

Rapid Progression of Adult T-Cell Leukemia/Lymphoma During PD-1 Inhibitor Therapy

In a letter to the editor in The New England Journal of Medicine, Ratner et al describe rapid progression of adult T-cell leukemia/lymphoma (ATLL) in three consecutive patients receiving programmed cell death protein 1 (PD-1) inhibitor therapy with nivolumab (Opdivo). As stated by the authors,...

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 ...

lymphoma
immunotherapy

2018 ASCO: Lenalidomide Plus Rituximab vs Rituximab Plus Chemotherapy in Previously Untreated Follicular Lymphoma

Results from RELEVANCE, a phase III, randomized, open-label, international clinical study conducted in partnership with the Lymphoma Academic Research Organisation (LYSARC), were presented by Fowler et al at the 2018 ASCO Annual Meeting (Abstract 7005). This study evaluated the investigational...

lymphoma
immunotherapy

FDA Expands Tisagenlecleucel Approval to Include Relapsed or Refractory Large B-Cell Lymphoma

On May 1, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah) suspension for intravenous infusion for the treatment of adult patients with relapsed or refractory large B-cell lymphoma—including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and...

lymphoma
skin cancer

Reciprocal Risks of Lymphoid Neoplasms and Cutaneous Melanoma

In a study reported in the Journal of the National Cancer Institute, Herr et al found that patients with specific types of primary lymphoid neoplasms were at increased risk of second primary cutaneous melanoma, with the reciprocal association also being observed. Occurrence of second primary...

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...

lymphoma
immunotherapy

Updated Analysis of Obinutuzumab in Rituximab-Refractory Indolent Non-Hodgkin Lymphoma

As reported in the Journal of Clinical Oncology by Cheson et al, an updated analysis of the phase III GADOLIN trial showed an overall survival advantage with obinutuzumab (Gazyva) plus bendamustine induction followed by obinutuzumab maintenance vs bendamustine alone in patients with rituximab...

lymphoma
immunotherapy

Extended Follow-up of Nivolumab Treatment in Relapsed/Refractory Classical Hodgkin Lymphoma After Failure of Autologous HCT

As reported by Armand and colleagues in the Journal of Clinical Oncology, extended follow-up of the phase II CheckMate 205 trial continues to show benefits and good tolerability of nivolumab (Opdivo) treatment in relapsed or refractory classical Hodgkin lymphoma after failure of autologous ...

lymphoma
immunotherapy

FDA Expands Approval of Brentuximab Vedotin for First-Line Treatment of Stage III or IV Classical Hodgkin Lymphoma in Combination With Chemotherapy

On March 20, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (Adcetris) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy. “Today’s approval represents an improvement in the initial...

solid tumors
lymphoma
immunotherapy

FDA Approves sBLA Updating Nivolumab Dosing Schedule Across Indications

On March 6, Bristol-Myers Squibb announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the nivolumab (Opdivo) dosing schedule to include 480 mg infused every 4 weeks for a majority of approved indications. This approval will ...

lymphoma
immunotherapy

FDA Accepts sBLA, Grants Priority Review for Tisagenlecleucel in Adults With DLBCL

Today, the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental Biologics License Application (sBLA) for tisagenlecleucel (Kymriah) suspension for intravenous infusion (formerly CTL019) for the treatment of adult patients with relapsed or refractory diffuse large...

lymphoma
immunotherapy

FDA Accepts sBLA, Grants Priority Review for Brentuximab Vedotin in Advanced Hodgkin Lymphoma

On January 2, the U.S. Food and Drug Administration (FDA) accepted for filing a supplemental Biologics License Application (sBLA) for brentuximab vedotin (Adcetris) in combination with chemotherapy for the front-line treatment of patients with advanced classical Hodgkin lymphoma. The FDA also...

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...

lymphoma

BTK Inhibitor in Relapsed or Refractory Mantle Cell Lymphoma

A phase II study (ACE-LY-004) reported in The Lancet by Wang et al showed durable responses with the Bruton tyrosine kinase inhibitor acalabrutinib (Calquence) in patients with relapsed or refractory mantle cell lymphoma. The study supported the recent approval of acalabrutinib in this setting....

lymphoma

CAR T-Cell Therapy in Refractory B-Cell Lymphomas

As reported at the recent American Society of Hematology Annual Meeting & Exposition and in The New England Journal of Medicine, Schuster et al found that chimeric antigen receptor (CAR) T-cell therapy produced responses in a high proportion of patients with B-cell lymphomas refractory to or...

lymphoma

ASH 2017: Acalabrutinib Demonstrates Activity in Relapsed or Refractory Mantle Cell Lymphoma

At the 59th American Society of Hematology (ASH) Annual Meeting & Exposition, Wang et al presented results from the open-label, single-arm phase II ACE-LY-004 clinical trial, which served as the basis for the recent U.S. Food and Drug Administration (FDA) accelerated approval of acalabrutinib...

lymphoma

ASH 2017: ALCANZA Trial: Brentuximab Vedotin in CD30-Expressing Cutaneous T-Cell Lymphoma

Updated results from the phase III ALCANZA clinical trial evaluating brentuximab vedotin (Adcetris) in CD30-expressing cutaneous T-cell lymphoma (CTCL) were presented by Horwitz et al at the 59th American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 1509). The presentation...

hematologic malignancies
leukemia
lymphoma
multiple myeloma

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...

lymphoma

ASH 2017: JULIET Trial: 6-Month Analysis of Tisagenlecleucel in Relapsed/Refractory DLBCL Shows Sustained Responses

Six months after receiving a single dose of tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell therapy that targets CD-19, high response rates persist among adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), according to findings reported by Schuster et al at...

lymphoma

ASH 2017: ZUMA-1: Responses to CAR T-Cell Therapy Still Strong After 1 Year in Patients With Refractory NHL

Among 108 patients with fast-growing and refractory aggressive non-Hodgkin lymphoma (NHL), more than half were still alive at least a year after receiving a single infusion of a CAR T-cell therapy called axicabtagene ciloleucel that targets the CD-19 protein frequently found on cancerous lymphoma...

lymphoma

ASH 2017: Addition of Brentuximab Vedotin to Multidrug Regimen Reduces Risk of First-Line Treatment Failure in Advanced Hodgkin Lymphoma

Patients with advanced Hodgkin lymphoma (HL) who were treated with a multidrug regimen that included the targeted agent brentuximab vedotin (Adcetris) had a 23% reduction in the risk of disease progression, death, or the need for additional therapy, compared with patients who received the standard...

lymphoma

ASH 2017: Targeted Antibody Mogamulizumab Superior to Vorinostat for Previously Treated CTCL in Phase III Trial

In a large, international, randomized phase III trial presented by Kim et al at the 59th American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 817), patients with previously treated cutaneous T-cell lymphoma (CTCL) who received the investigational targeted drug...

lymphoma

ASH 2017: Sustained Benefit With Ibrutinib in Relapsed or Refractory Mantle Cell Lymphoma

The results of a pooled analysis of patients with relapsed or refractory mantle cell lymphoma (MCL) treated with ibrutinib (Imbruvica) were presented at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 151). The extended follow-up data demonstrated that...

hematologic malignancies
leukemia
lymphoma
multiple myeloma

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...

lymphoma

Patients With HIV-Associated Lymphoma Can Safely Continue Antiretroviral Therapy During Chemotherapy

Patients with human immunodeficiency virus (HIV) who are treated with combination antiretroviral therapy (cART) can safely undergo chemotherapy to treat associated lymphomas at the same time, researchers from the AIDS Malignancy Consortium have found. These findings were published by Tan et al in...

lymphoma

Adding Antibody-Drug Conjugate to First-Line Treatment of Advanced Classical Hodgkin Lymphoma

As reported by Eichenauer et al in The Lancet Oncology, the final results of a phase II German Hodgkin Study Group trial showed similar efficacy but a better toxicity profile for BrECADD (brentuximab vedotin [Adcetris], etoposide, doxorubicin, cyclophosphamide, dacarbazine, dexamethasone) vs...

lymphoma

FDA Approves Obinutuzumab for Previously Untreated Advanced Follicular Lymphoma

On November 16, Genentech announced that the U.S. Food and Drug Administration (FDA) approved obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III, or...

lymphoma

Long-Term Results of First-Line Regimens in Advanced Symptomatic Follicular Lymphoma

Long-term results of the Italian phase III FOLL05 trial, reported by Luminari et al in the Journal of Clinical Oncology, indicate superior progression-free survival with R-CHOP (rituximab [Rituxan] plus cyclophosphamide, doxorubicin, vincristine, and prednisone) and R-FM (rituximab plus fludarabine ...

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