CHMP backs blinatumomab for MRD

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Vials of blinatumomab powder
and solution for infusion
Photo courtesy of Amgen
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding marketing authorization for blinatumomab (Blincyto) to include treatment of minimal residual disease (MRD). The CHMP has recommended approval for blinatumomab as monotherapy for adults with Philadelphia chromosome-negative,... [Read Article]
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Eltrombopag approved as first-line SAA therapy

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Eltrombopag (Promacta)
Photo courtesy of GSK
The U.S. Food and Drug Administration (FDA) has expanded the approved use of eltrombopag (Promacta®) in severe aplastic anemia (SAA). Eltrombopag is now approved for use in combination with standard immunosuppressive therapy as first-line treatment for adults and pediatric patients age 2 and older with SAA. Eltrombopag received... [Read Article]
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Quick FDA approval for brentuximab vedotin in PTCL

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Brentuximab vedotin
Photo from Business Wire
The U.S. Food and Drug Administration (FDA) has approved a new indication for brentuximab vedotin (ADCETRIS®) less than 2 weeks after receiving the completed supplemental biologics license application (sBLA). Brentuximab vedotin is now approved for use in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) to treat adults with... [Read Article]
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FDA approves generic drugs for APL

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Fresenius Kabi’s
arsenic trioxide
Photo from Business Wire
The U.S. Food and Drug Administration (FDA) has now approved three generic arsenic trioxide products for use in patients with acute promyelocytic leukemia (APL). Two of the products—from Zydus Cadila and Amring Pharmaceuticals—were approved on November 13. The third—from Fresenius Kabi—was approved in August and launched... [Read Article]
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FDA approves generic decitabine for MDS

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Micrograph showing MDS
The U.S. Food and Drug Administration has approved Lupin’s decitabine product, a generic version of Otsuka Pharmaceutical Co. Ltd.’s Dacogen, to treat patients with myelodysplastic syndromes (MDS). Lupin’s decitabine for injection (50 mg, single-dose vial) is approved to treat patients with intermediate-1, intermediate-2, and high-risk MDS. This includes previously treated, untreated,... [Read Article]
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Health Canada approves two tests for CML patients

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CML cells
Image by Difu Wu
Health Canada has approved the use of two tests designed to detect BCR-ABL transcripts in patients with chronic myeloid leukemia (CML)—the MRDx® BCR-ABL Test and the QuantideX qPCR BCR-ABL IS Kit. MolecularMD’s MRDx® BCR-ABL Test is approved as an aid to monitor tyrosine kinase inhibitor (TKI) therapy in Philadelphia... [Read Article]
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Markers associated with efficacy of malaria vaccine

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Child receiving RTS,S/AS01
Photo by Caitlin Kleiboer
New research has revealed markers associated with efficacy of the RTS,S/AS01E malaria vaccine (Mosquirix™). The study suggests malaria protection depends on the amount and subclass of antibodies generated upon vaccination and on previous exposure levels to the malaria parasite. Researchers believe these findings, published in BMC Medicine,... [Read Article]
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FDA clears instrument for blood typing, screening

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Blood samples
Photo by Graham Colm
The U.S. Food and Drug Administration has granted marketing clearance for the immunohematology instrument NEO Iris™. NEO Iris is a fully automated blood bank instrument designed for the mid- to high-volume laboratory, according to Immucor, Inc., the company marketing the device. Immucor says NEO Iris provides the highest... [Read Article]
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‘Compelling’ new target found for monocytic AML

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Chengcheng “Alec” Zhang, PhD
Photo from University of Texas Southwestern Medical Center
Efforts to determine why immune checkpoint blockade is not successful in treating leukemia have resulted in a “compelling” new target to treat monocytic acute myeloid leukemia (AML), according to researchers. They discovered that leukocyte immunoglobulin-like receptor B4 (LILRB4), a marker of monocytic... [Read Article]
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Triplet improves PFS in relapsed/refractory MM

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Micrograph showing
multiple myeloma
Adding elotuzumab to pomalidomide and low-dose dexamethasone can improve progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (MM), according to the ELOQUENT-3 trial. These results support the recent U.S. approval of elotuzumab, pomalidomide, and dexamethasone in adults with MM who have received at least two prior therapies, including... [Read Article]
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CAR T therapy for MM receives RMAT designation

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Micrograph showing MM
P-BCMA-101, an autologous chimeric antigen receptor (CAR) T-cell therapy being developed to treat patients with relapsed/refractory multiple myeloma (MM), has received regenerative medicine advanced therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA). RMAT designation is intended to expedite the development and review of regenerative medicines that are intended to... [Read Article]
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Vaccine inhibits thrombus formation in mice

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Lab mouse
Investigators designed an antiplatelet vaccine they say could be a novel therapy to prevent recurrent ischemic stroke. The vaccine inhibits S100A9/CD36 signaling in platelets, which is a key signal in arterial thrombosis but not hemostasis. Mice immunized with the vaccine experienced an antithrombotic effect that lasted 84 days. The vaccine inhibited thrombus formation... [Read Article]
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Combo worsens platelet recovery in MDS

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Eltrombopag (Promacta)
Photo courtesy of GSK
Results from the phase 3 SUPPORT trial suggest there is no role for the combination of eltrombopag and azacitidine in patients with intermediate- or high-risk myelodysplastic syndromes (MDS), according to investigators. Adding eltrombopag to azacitidine worsened platelet recovery, reduced the overall response rate, and did not improve overall... [Read Article]
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Molecule enhances PI activity in multiple myeloma

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Theoretical binding
of E64FC26 to PDI
Image from Reeder
Robinson of MUSC
Researchers say they have identified a new class of protein disulfide isomerase (PDI) inhibitors that sensitize multiple myeloma (MM) cells to proteasome inhibitors (PIs). The investigators screened approximately 20,000 compounds spanning multiple chemical libraries and found the compound E61 to be a “striking... [Read Article]
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