Midostaurin approved to treat AML, SM in Europe

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Midostaurin (Rydapt) capsules
Photo courtesy of Novartis
The European Commission has approved the multi-targeted kinase inhibitor midostaurin (Rydapt®) to treat acute myeloid leukemia (AML) and 3 types of advanced systemic mastocytosis (SM). Midostaurin is approved to treat adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive. In these patients,... [Read Article]
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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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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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Antibody shows early promise in AML/MDS trial

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Micrograph showing MDS
Interim results of a phase 1 study suggest flotetuzumab, a CD123 and CD3 bispecific antibody, may be a feasible treatment option for relapsed or refractory acute myeloid leukemia (AML) or intermediate/high-risk myelodysplastic syndromes (MDS). Researchers said flotetuzumab demonstrated acceptable tolerability in the dose-escalation portion of the study, with infusion-related reactions... [Read Article]
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CHMP advocates refusal of application for SM drug

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Mast cells
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended refusal of the marketing authorization for masitinib (Masipro). Masitinib is a tyrosine kinase inhibitor being developed by AB Science to treat adults with smoldering or indolent severe systemic mastocytosis (SM). To support the application for masitinib, AB... [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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Immune status linked to outcomes of CAR T-cell therapy

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Micrograph showing DLBCL
Outcomes of treatment with a third-generation chimeric antigen receptor (CAR) T-cell therapy are associated with a patient’s immune status, according to a phase 1/2a trial. The CD19-specific CAR T-cell therapy produced a complete response (CR) in 6 of 15 patients with relapsed/refractory CD19-positive leukemia or lymphoma. Though all responders eventually... [Read Article]
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