FDA grants RMAT designation to HSCT adjunct

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T cells
Image from NIAID
The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ATIR101™, which is intended to be used as an adjunct to haploidentical hematopoietic stem cell transplant (HSCT). ATIR101 is a personalized T-cell immunotherapy—a donor lymphocyte preparation selectively depleted of host-alloreactive T cells through... [Read Article]
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FDA grants orphan designation to product for GVHD

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Hematopoietic stem cell
transplant preparation
Photo by Chad McNeeley
The US Food and Drug Administration (FDA) has granted orphan drug designation to ApoGraft™ as prophylaxis for acute and chronic graft-versus-host disease (GVHD) in transplant recipients. ApoGraft is a mobilized peripheral blood cell product collected via apheresis from a matched, related donor. The product... [Read Article]
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Lenalidomide maintenance prolongs PFS, OS in MM

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Lenalidomide (Revlimid)
Photo courtesy of Celgene
Lenalidomide maintenance can be considered a standard of care for multiple myeloma (MM) patients who have undergone hematopoietic stem cell transplant (HSCT), according to researchers. A meta-analysis of data from 3 trials showed that lenalidomide maintenance extended both progression-free survival (PFS) and overall survival (OS) in these... [Read Article]
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VSTs can treat 5 different viral infections after HSCT

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Ifigeneia Tzannou
(left) and Bilal Omer
Photo from Baylor
College of Medicine
New research suggests virus-specific T cells (VSTs) can protect patients from severe viral infections that sometimes occur after hematopoietic stem cell transplant (HSCT). The VSTs proved effective against 5 different viruses—Epstein-Barr virus (EBV), adenovirus (AdV), cytomegalovirus (CMV), BK virus (BKV), and... [Read Article]
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Tests can produce confusing results after HSCT in MM

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icrograph showing MM
Tests used to assess treatment response in multiple myeloma (MM) may often produce confusing results after patients have undergone hematopoietic stem cell transplant (HSCT), a new study suggests. The tests—serum protein electrophoresis/serum immunofixation electrophoresis (SPEP/SIFE) and serum free light chain assay (SFLCA)—can sometimes produce an oligoclonal pattern that can be... [Read Article]
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Drug receives orphan designation for ocular GVHD

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Hematopoietic stem cell transplant preparation
Photo by Chad McNeeley
The US Food and Drug Administration (FDA) has granted orphan drug designation to OCU300 (brimonidine tartrate) for the treatment of ocular graft-versus-host disease (oGVHD) occurring after allogeneic hematopoietic stem cell transplant. Brimonidine tartrate is an alpha adrenergic agonist that is already FDA-approved to lower... [Read Article]
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