Latest & Greatest

Latest & Greatest

Recent developments in the field of hematology/oncology, including drug approvals, policy updates, and clinical trial results

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

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

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

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...

FDA Grants Accelerated Approval to Copanlisib for Relapsed FL

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...

FDA Accepts Application for Rituximab Biosimilar for Several Indications

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),...

Obinutuzumab Receives Priority Review for Follicular Lymphoma

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

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

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...

First CAR T-Cell Therapy for Pediatric Leukemia Gains FDA Approval

The U.S. Food and Drug Administration (FDA) approved the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel for the treatment of pediatric and young adult...

Dasatinib Receives Priority Review for New CML Indications

The U.S. Food and Drug Administration (FDA) granted priority review to dasatinib, a tyrosine kinase inhibitor, for pediatric patients with chronic myeloid leukemia (CML). The...
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Current Issue

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.