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Cell Therapy News
Lisocabtagene maraleucel could be ‘CAR T-cell treatment of choice’ for lymphoma subset
Nearly three-quarters of patients who received lisocabtagene maraleucel for relapsed or refractory large B-cell lymphoma achieved objective response, according to results of the TRANSCEND NHL 001 trial published in The Lancet.
FDA grants orphan drug designation to CAR T-cell therapy for advanced gastric cancers
The FDA granted orphan drug designation to CT041 for the treatment of adults with relapsed or refractory gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, according to the agent’s manufacturer.
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FDA grants fast track designation to ‘switchable’ CAR-T for B-cell malignancies
The FDA granted fast track designation to CLBR001 + SWI019, a chimeric antigen receptor T-cell therapy designed to treat B-cell malignancies, according to the agent’s developer.
FDA seeks more data about cell therapy for pediatric GVHD
The FDA issued a complete response letter to a biologics license application that seeks approval of remestemcel-L to treat certain children with graft-versus-host disease.
New guideline for multiple myeloma to aid clinicians with limited immunotherapy experience
The Society for Immunotherapy of Cancer issued a clinical practice guideline on the use of immunotherapy for the treatment of multiple myeloma.
City of Hope reaches deal to commercialize scorpion toxin-based CAR T-cell therapy
City of Hope announced it has reached an agreement with Australia-based biotech Chimeric Therapeutics.
Getting to the heart of CAR T-cell therapy’s cardiovascular risks
How much risk is too much? It depends on what is at stake.
CAR-T plus pembrolizumab shows ‘superior’ safety, promising responses in advanced lymphoma
No patients who received pembrolizumab with a CD19/CD22-directed chimeric antigen receptor T-cell therapy experienced high-grade cytokine release syndrome, according to phase 1 study findings presented during ESMO Virtual Congress 2020.
Institute issues draft scoping plan for review of anti-BCMA therapies for multiple myeloma
The Institute for Clinical and Economic Review has completed a draft scoping document for its planned assessment of chimeric antigen receptor T-cell therapies for the treatment of multiple myeloma.
FDA grants priority review to idecabtagene vicleucel for advanced multiple myeloma
The FDA granted priority review to idecabtagene vicleucel for the treatment of certain adults with relapsed or refractory multiple myeloma, according to the agent’s developers.