November 2017, Volume 3, Issue 13

November 2017

Volume 3, Issue 13

This issue features a behind-the-scenes look at the ASH annual meeting, bringing newly approved gene therapies to patients, and more.

Table of Contents

November 2017 Issue

A Thought-Provoking Question

Wednesday, November 1st, 2017
In our September issue, Elisabeth M. Battinelli, MD, PhD, responded to a colleague seeking advice on managing a patient who developed deep-vein thrombosis (DVT)...

Treating Spin Doctors

Wednesday, November 1st, 2017
Recently, a hospital in Boston announced that a senior staff scientist had developed a “cure” for leukemia. I wasn’t surprised to read this –...

November 2017 Issue

Remembering Harold Roberts and Tessa Holyoake, CRISPR Researchers Awarded Albany Medical Center Prize, and...

Wednesday, November 1st, 2017
Remembering Harold R. Roberts, MD Harold R. Roberts, MD, a leader in the field of thrombosis and hemostasis and two-time American Society of Hematology (ASH)...

ASH Announces New Executive Committee Members, ASH Members Visit Congress, and more

Wednesday, November 1st, 2017
The Results Are In … ASH Announces 2018 Executive Committee Members ASH announced the election of four new members to its Executive Committee, the governing...

November 2017 Issue

A Behind-the-Scenes Look at the ASH Annual Meeting

Wednesday, November 1st, 2017
Every December, tens of thousands of researchers, clinicians, and health-care stakeholders gather for the American Society of Hematology’s (ASH) annual meeting. More than a...

When Life Gives You Venoms… : Mrinal Patnaik, MBBS

Wednesday, November 1st, 2017
In this edition, Mrinal Patnaik, MBBS, explains his fascination with snakes and how venomous reptiles have contributed to hematology. Dr. Patnaik is associate professor...

Fighting for Hematology: ASH Bridge Grants and Grassroots Advocacy

Wednesday, November 1st, 2017
After years of across-the-board funding cuts and steady budget declines, the National Institutes of Health (NIH) received a $2 billion increase in funding with...

Off to the CAR T Races: Bringing CAR T-Cell Therapies to Cancer Patients

Wednesday, November 1st, 2017
August 30, 2017, marked a milestone for medicine: The cell-based gene therapy tisagenlecleucel became the first U.S. Food and Drug Administration (FDA)–approved treatment that...

Pulling Back the Curtain: Donna DiMichele, MD

Wednesday, November 1st, 2017
In this edition, Donna DiMichele, MD, reveals the careers she imagined herself in had she not pursued medicine, and how her first summer jobs...

November 2017 Issue

How should you treat a patient with lymphoma who developed “chemo brain” after R-CHOP...

Wednesday, November 1st, 2017
This month, Carol S. Portlock, MD, discusses neurologic toxicity following R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone). And don't forget to check out next month's clinical dilemma...

November 2017 Issue

First CAR T-Cell Therapy for B-Cell Lymphoma Receives FDA Approval

Wednesday, November 1st, 2017
The U.S. Food and Drug Administration (FDA) approved the chimeric antigen receptor (CAR) T-cell therapy axicabtagene ciloleucel (or KTE-C19) for the treatment of adult...

Manufacturer Suspends Trial of Fitusiran for Hemophilia After Patient Death

Wednesday, November 1st, 2017
Alnylam Pharmaceuticals, Inc., suspended a phase II trial of its investigational RNA inhibitor fitusiran for patients with hemophilia after a patient with hemophilia A...

Brentuximab Vedotin Receives Priority Review for CTCL

Wednesday, November 1st, 2017
The U.S. Food and Drug Administration (FDA) granted priority review to the anti-CD30 monoclonal antibody brentuximab vedotin (BV) for the treatment of cutaneous T-cell...
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Predicting the Risk and Severity of Cytokine Release Syndrome in Patients Receiving CAR T-Cell...

Wednesday, November 1st, 2017
While treatment with CD19-directed chimeric antigen receptor (CAR) T cells has demonstrated impressive response rates of over 80% in select patients with B-cell malignancies,...
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Adding Rituximab to Corticosteroids and Cyclosporine A in Patients With cGVHD Improves ORR

Wednesday, November 1st, 2017
Standard firstline treatment for chronic graft-versus-host disease (cGVHD) includes corticosteroids and cyclosporine A, but disease control often requires long-term immunosuppressive treatment, which impairs patients’...

Combination Antiplatelet Therapy Associated With Higher Mortality After ICH Than Single Antiplatelet Therapy

Wednesday, November 1st, 2017
Antiplatelet therapy (APT) is associated with increased risk of intracerebral hemorrhage (ICH), though data about the association between APT use and mortality risk after...

Post-AHCT Maintenance Therapy With Rituximab Prolongs Survival in MCL

Wednesday, November 1st, 2017
Maintenance therapy with the anti-CD20 monoclonal antibody rituximab after autologous hematopoietic cell transplantation (AHCT) prolonged event-free, progression-free, and overall survival in patients with mantle...

Treating Financial Toxicity: Subsidies Improve Access to Oral Therapies for Medicare Beneficiaries With Myeloma

Wednesday, November 1st, 2017
Low-income subsidies (LIS), which are available to Medicare beneficiaries who earn less than 150 percent of the federal poverty level, alleviate the financial burden...
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Examining Ibrutinib as Secondline Therapy for Chronic Graft-Versus-Host Disease

Wednesday, November 1st, 2017
On August 2, 2017, the U.S. Food and Drug Administration (FDA) approved the Bruton tyrosine kinase inhibitor ibrutinib as a secondline treatment for adult...

Real-World Analysis Confirms Rivaroxaban Reduces Risk of VTE and Major Bleeding, Compared With Warfarin

Wednesday, November 1st, 2017
Previously, a series of phase III trials from EINSTEIN investigators determined that the direct oral anticoagulant (DOAC) rivaroxaban is non-inferior to enoxaparin and warfarin...
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Early Study Shows Venetoclax Is Active in Patients With Relapsed/Refractory Myeloma and t(11;14)

Wednesday, November 1st, 2017
Venetoclax, an oral BCL2 inhibitor approved by the U.S. Food and Drug Administration for the treatment of chronic lymphocytic leukemia, may be a treatment...
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Can Genomics Predict Which Patients With Aplastic Anemia Will Develop MDS?

Wednesday, November 1st, 2017
Patients with aplastic anemia (AA) can develop clonal disorders, such as paroxysmal nocturnal hemoglobinuria (PNH) and secondary myelodysplastic syndromes (sMDS). “Distinguishing from those...

FDA Grants Accelerated Approval to Copanlisib for Relapsed FL

Wednesday, November 1st, 2017
The U.S. Food and Drug Administration (FDA) granted accelerated approval for copanlisib for adults with relapsed follicular lymphoma (FL) who have received at least...
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Hydroxyurea Treatment Impairs Spermatogenesis in Men With SCA

Wednesday, November 1st, 2017
The prognosis for patients living with sickle cell anemia (SCA) has improved in the past few decades, thanks in part to the availability of...
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Examining Ibrutinib as Secondline Therapy for cGVHD

Wednesday, November 1st, 2017
On August 2, 2017, the U.S. Food and Drug Administration (FDA) approved the Bruton tyrosine kinase inhibitor ibrutinib as a secondline treatment for adult...

The Ins and Outs of Inclusion Criteria for Myeloma Clinical Trials

Wednesday, November 1st, 2017
Clinical trial protocols often incorporate strict eligibility criteria to maximize reproducible, results with minimal risk to trial participants. Unfortunately, restricting a trial’s patient population...

FDA Accepts Application for Rituximab Biosimilar for Several Indications

Wednesday, November 1st, 2017
The U.S. Food and Drug Administration (FDA) accepted a biologics license application for the rituximab biosimilar GP2013 for the treatment of follicular lymphoma (FL),...
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Examining Anemia, Hemolysis Markers, and Vascular Complications of Sickle Cell Disease in Sub-Saharan Africa

Wednesday, November 1st, 2017
Previous studies of patients with sickle cell disease (SCD) suggested that certain patients are at risk for “hyperhemolysis,” characterized by a pattern of lower...

Obinutuzumab Receives Priority Review for Follicular Lymphoma

Wednesday, November 1st, 2017
The U.S. Food and Drug Administration (FDA) granted priority review to the anti-CD20 monoclonal antibody obinutuzumab in combination with chemotherapy, followed by obinutuzumab alone,...

FDA Approves Gemtuzumab Ozogamicin for AML

Wednesday, November 1st, 2017
The U.S. Food and Drug Administration (FDA) approved gemtuzumab ozogamicin (GO) for two patient populations: adults with newly diagnosed CD33-positive acute myeloid leukemia (AML)...

FDA Places Holds on Clinical Trials of PD-1 Inhibitor Durvalumab

Wednesday, November 1st, 2017
The U.S. Food and Drug Administration (FDA) placed partial clinical holds on five trials and a full clinical hold on one trial of the...

Low Fetal Hemoglobin May Predict Silent Brain Lesions in Patients With Sickle Cell Disease

Wednesday, November 1st, 2017
Silent white-matter changes (WMC) – permanent neurologic injuries that can cause cognitive deficits and intellectual decline – are common in patients with sickle cell...

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