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FDA Reports of Secondary Malignancies Following Chimeric Antigen Receptor (CAR) T Cell Therapies and Relative Risk: an EBMT-EHA-GoCART Coalition Statement

We need to bring your attention to the recent warning disseminated by the Food and Drug Administration (FDA) regarding T-cell lymphomas in patients undergoing Chimeric Antigen Receptor T-cell (CAR-T) therapy (1).

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Addition of obinutuzumab (GA101) or rituximab to chlorambucil improves outcomes for elderly patients with chronic lymphocytic leukemia (CLL) and co-existing medical conditions (comorbidities)

CLL is the most common leukemia in the western world. Many CLL patients are elderly and have comorbidities rendering them ineligible for aggressive standard treatments.

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SWG Educational Activities

EICMLThe 2023 EICML meeting took place in Naples in May 2023. Fifty-five physicians and scientists met at the Palazzo Alabardieri in central Naples to spend two days discussing emerging data and developing collaborations.

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Mini-hormone fights iron

Iron overload commonly leads to organ damage and even death. Currently available treatments for iron overload are burdensome or cause side effects.

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EHA at ICH meeting: Excessive bureaucracy harms patient safety and innovation

To solicit input from a wide range of non-ICH members about the revision of ICH E8(R1), ICH held a Public Meeting on ICH E8(R1) “General Considerations for Clinical Studies” (Silver Spring, USA, October 31, 2019).

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First randomized evidence for kinase inhibitor activity in acute myeloid leukemia

Despite the success of tyrosine kinase inhibitors in some forms of leukemias such as chronic myeloid leukemia and acute lymphoblastic leukemia, until now a kinase inhibitor had yet to demonstrate activity in acute myeloid leukemia (AML).

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Selected EMA news

November 2024New medicines recommended for approval
Eltrombopag Viatris (eltrombopag) – generic
Treatment of primary immune thrombocytopenia and thrombocytopenia associated with chronic hepatitis C (disease in which patients have low levels of blood platelets)

Alhemo (concizumab)
Prevention of bleeding in patients with hemophilia A…

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GAPP Joint Action

Joint Actions are projects designed and financed by Member State Authorities and the EU to address specific priorities under the EU Health Program.

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