Team creates guidelines on CAR T-cell-related toxicity

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Sattva Neelapu, MD
Photo courtesy of MD
Anderson Cancer Center
Researchers say they have created guidelines for managing the unique toxicities associated with chimeric antigen receptor (CAR) T-cell therapy. The guidelines focus on cytokine release syndrome (CRS); neurological toxicity, which the researchers have dubbed “CAR-T-cell-related encephalopathy syndrome (CRES);” and adverse effects related to... [Read Article]
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Trials of atezolizumab placed on partial hold

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Atezolizumab (Tecentriq)
Photo from Genentech
Roche has announced a partial clinical hold on 2 trials of the anti-PD-L1 antibody atezolizumab (Tecentriq). One is a phase 1b/2 study (NCT02631577) in which researchers are evaluating atezolizumab in combination with obinutuzumab plus lenalidomide in patients with relapsed or refractory follicular lymphoma. The other is a phase... [Read Article]
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Application for pegfilgrastim biosimilar withdrawn

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Vials of drug
Mylan S.A.S. has withdrawn the European marketing authorization application for its pegfilgrastim biosimilar Fulphila, according to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). Fulphila was intended to be used to reduce the duration of neutropenia and the incidence of febrile neutropenia in adults receiving cytotoxic... [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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FDA warns about risk of death with pembrolizumab in MM

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Pembrolizumab (Keytruda)
Photo courtesy of Merck
The US Food and Drug Administration (FDA) has issued a statement warning about an increased risk of death associated with an unapproved use of pembrolizumab (Keytruda). Results from 2 clinical trials have shown that combining pembrolizumab with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) increases the... [Read Article]
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