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A Look Back at FDA News in the Month of March

Several new indications were approved by the FDA in March, including blinatumomab (Blincyto) for MRD+ ALL, brentuximab vedotin (Adcetris) for Hodgkin lymphoma, and a 4-week nivolumab (Opdivo) dosing schedule across several indications. Here’s a look back on the FDA happenings for the month of March 2018.

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FDA Grants Moxetumomab Pasudotox Priority Review for Hairy Cell Leukemia

The FDA has granted a priority review to moxetumomab pasudotox for the treatment of adult patients with hairy cell leukemia who have received at least 2 prior lines of therapy.

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Denosumab Granted European Approval for Myeloma

Based on data from the Phase 3 482 trial, denosumab (Xgeva) has been approved for an expanded indication by the European Commission for the prevention of skeletal-related events in adult patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor.

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Denosumab Approved in Europe for Myeloma

The European Commission has approved denosumab for the prevention of skeletal-related events in adult patients with multiple myeloma.

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Nivolumab Delivers Durable Response in Hodgkin Lymphoma at 18 Months

In an extended follow-up of results from the CheckMate-205 trial, nivolumab (Opdivo) induced an overall objective response rate of 69% in patients with relapsed/refractory classical Hodgkin lymphoma after autologous hematopoietic cell transplantation.

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Novel Radiolabeled ADC Could Improve Outcomes in High-Risk AML

Older patients with active, relapsed, or refractory acute myeloid leukemia have a low survival rate, very poor risk assessments, and limited therapeutic options, with conventional care consisting primarily of salvage chemotherapy.

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MRD Prognostic of Poorer Outcomes in AML

Molecular minimal residual disease was associated with a higher rate of relapse and a lower rate of relapse-free survival and overall survival for patients with newly-diagnosed acute myeloid leukemia.

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Expert Discusses Next Steps After Dramatic Shift in Management of AML

Stuart L. Goldberg, MD, discussed the management of patients with acute myeloid leukemia as well as those with myelodysplastic syndrome.

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Ongoing Advances Transforming Treatment in Myeloma

Noa Biran, MD, discusses treatment breakthroughs and emerging advances in the field of multiple myeloma.

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AML Treatment Additions Encouraging, But MDS Landscape Still Facing Challenges

Stuart L. Goldberg, MD, discusses the management of patients with acute myeloid leukemia as well as those with myelodysplastic syndrome.

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Pereira Offers View on the Importance of Maintenance Therapy for patients With Multiple...

Denise. L. Pereira, MD, recently shared the treatment considerations and decisions she makes when treating patients with multiple myeloma based on 2 case scenarios during a Targeted Oncology live case-based peer perspectives presentation.

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MURANO trial Results Demonstrate PFS Benefit with Venetoclax/Rituximab

According to findings from the Phase 3 MURANO trial recently published in the New England Journal of Medicine, the venetoclax (Venclexta) plus rituximab (Rituxan) regimen lowered the risk of disease progression or death by 83% in comparison with bendamustine (Treanda) plus rituximab (Rituxan) in patients with relapsed or refractory chronic lymphocytic leukemia.

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EBRT Effective in Relapsed/Refractory Follicular Lymphoma

Findings from a small, retrospective trial delivered that external beam radiation therapy induced an overall response rate of 86% in patients with relapsed/refractory follicular lymphoma.

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Combined Radiation Therapy and Checkpoint Inhibition in Lymphoma: A Case Report and Brief Review

The emergence of immune checkpoint inhibitors as an effective treatment strategy is a result of increased understanding of the elaborate relationship between tumor cells, their microenvironment and the host immune response.

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Blinatumomab Granted FDA Approval for MRD+ ALL

Blinatumomab (Blincyto) has been granted an accelerated approval by the FDA for the treatment of patients with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease.

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Nilotinib Granted FDA Approval for Pediatric CML

Based on data from 2 clinical trials, nilotinib (Tasigna) has been approved by the FDA for the first- and 2nd-line treatment of pediatric patients aged 1 year and older with Philadelphia chromosome–positive chronic myeloid leukemia in the chronic phase.

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FDA Grants Accelerated Approval to Blinatumomab for the Treatment of B-cell Precursor ALL

It is indicated in adult and paediatric patients in first or second complete remission with minimal residual disease

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Cheson Considers the Most Effective Therapeutic Strategies for patients With Follicular...

Bruce D. Cheson, MD, recently shared the treatment options and decisions he makes when treating patients with follicular lymphoma based on 2 case scenarios during a Targeted Oncology live case-based peer perspective presentation.

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Combination of Atezolizumab and Cobimetinib Active in mCRC

The combinations of atezolizumab and cobimetinib induced a 31% disease control rate in patients with heavily-pretreated metastatic colorectal cancer. Results from a 2-stage phase Ib trial presented at the 2018 Gastrointestinal Cancers Symposium demonstrated an overall response rate of 8% (n = 7). All responses were partial responses.

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FDA Approves Blinatumomab for MRD+ ALL

The FDA has approved blinatumomab for the treatment of patients with minimal residual disease–positive B-cell precursor acute lymphoblastic leukemia.

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EMA Suggests Extension of Therapeutic Indications for Denosumab

Extension of indication includes the avoidance of skeletal-related events in grown-ups with late-stage malignancies involving the bone

On 22 February 2018, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending towards a change in the marketing authorisation for denosumab (licensee: Amgen Europe BV).

The following extension of the label was adopted by the CHMP:

  • Prevention of skeletal-related events in adults with advanced malignancies involving bone (e.g. pathological fracture, radiation to the bone, spinal cord compression, or surgery to the bone).

Previously, denosumab was only indicated for the prevention of skeletal-related events in adults with bone metastases from solid tumours.

Reference:
http://www.esmo.org/Oncology-Information/EMA-Endorses-Extension-of-Therapeutic-Indications-for-Denosumab2

FDA Approves Brentuximab Vedotin for Previously Untreated Stage III or IV Classical Hodgkin Lymphoma

Approval is based on results from the ECHELON-1 trial

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Brentuximab Vedotin Approved by FDA for Hodgkin Lymphoma

Brentuximab Vedotin Approved by FDA for Hodgkin Lymphoma

2018-03-29 10:42:10

Based on findings from the Phase 3 ECHELON-1 trial, brentuximab vedotin (Adcetris) has been approved by the FDA for use in combination with chemotherapy as a frontline treatment for adult patients with stage III or IV classical Hodgkin lymphoma, according to a statement from Seattle Genetics, the manufacturer of the CD30-targeted antibody-drug conjugate.

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Oncology Breast CNS Chemotherapy Endocrine GI GU Geriatric Gynecologic GYN-OB Head and Neck Haematology Immunotherapy Lung Melanoma Skin NET Paediatric Pathology Sarcoma Surgery Targeted Therapy Translational

Durable Responses to JCAR017 Observed in High-Risk DLBCL

2018-03-29 10:30:12

Responses to lisocabtagene maraleucel have been potent and durable in the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma. Separate exploratory analyses of this population treated with liso-cel found that high tumor burden and a series of in ammatory biomarkers were associated with high chimeric antigen receptor T-cell expansion and higher rates of cytokine release syndrome and neurotoxicity.

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FDA Approves Nilotinib for Paediatric patients with Newly Diagnosed or Resistant/Intolerant Ph-Positive CML in Chronic Phase

2018-03-28 22:16:00

Approval is based on results in paediatric patients from CAMN107A2120 and CAMN107A2203 studies

Source