Latest & Greatest

Latest & Greatest

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

FDA Places Partial Clinical Hold on Selinexor for Multiple Myeloma

The FDA placed clinical trials of selinexor on a partial hold, halting enrollment of new patients in the studies but allowing those who have...

FDA Clears Device That Touts “Fast and Virtually Painless” Blood Draw

The FDA granted 510(k) clearance to TAP, a blood collection device that is placed on the upper arm and collects 100 µL of capillary...

FDA Grants Marketing Authorization for Personal Genetic Risk Tests

The FDA has approved marketing for 23andMe Personal Genome Service Genetic Health Risk (GHR) tests, the first direct-to-consumer tests that analyze DNA from users’...

Development of CAR T-Cell Therapy for Acute Lymphocytic Leukemia Shut Down Following Clinical Holds

Juno Therapeutics, the manufacturer of the experimental chimeric antigen receptor (CAR) therapy JCAR015 for patients with relapsed acute lymphocytic leukemia, announced that it will...

Trials of Vadastuximab Talirine to Resume After FDA Clinical Hold

The FDA lifted its clinical hold on early-stage studies of vadastuximab talirine for AML after halting them in early January following four patient deaths. Seattle...

FDA Grants Priority Review of Enasidenib for Acute Myeloid Leukemia

The FDA granted priority review of enasidenib for patients with relapsed/refractory IDH2-mutated acute myeloid leukemia (AML). The decision was based on results of the single-arm,...

FDA Approves Pembrolizumab for Classic Hodgkin Lymphoma

The FDA approved the anti-PD-1 monoclonal antibody pembrolizumab for adults and children with classic Hodgkin lymphoma who are refractory to treatment or who have...

FDA Approves Lenalidomide for Maintenance Therapy in Multiple Myeloma

The U.S. Food and Drug Administration (FDA) expanded the approval of lenalidomide to include maintenance therapy for patients with multiple myeloma (MM) who have...

FDA Revisits Off-Label Communication in Draft Guidance for Medical Product Labeling

In response to requests from drug manufacturers that they be able to communicate supplementary data and information about a product’s “off-label” uses in promotional...

Start-Up Plans to Raise $1 Billion to Develop Liquid Biopsy to Detect Cancer

The biotechnology start-up Grail recently announced its plan to raise $1 billion in financing to create a liquid biopsy assay that could detect cancer...
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Current Issue

May 2017, Volume 3, Issue 6

This issue discusses the legacy of Agent Orange and hematologic malignancies, a debate over transplant in myelodysplastic syndromes, and more.