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Cell Therapy News
Earlier CAR-T treatment possible if price comes down, FDA official says
Expanded use of chimeric antigen receptor T cells for cancer treatment requires that less expensive therapies be developed faster using multiple manufacturing models, according to an FDA official.
FDA grants priority review to Kymriah for advanced follicular lymphoma
The FDA granted priority review to tisagenlecleucel, a chimeric antigen receptor T-cell therapy, for treatment of adults with relapsed or refractory follicular lymphoma who received two prior lines of therapy.
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FDA clears application for anti-PD-1 CAR-T to treat hematologic, breast cancers
The FDA cleared an investigational new drug application for PRGN-3007, a chimeric antigen receptor T-cell therapy for patients with advanced hematologic malignancies or solid tumors that express receptor tyrosine kinase-like orphan receptor 1.
Point-of-care manufacturing offers ‘treat it when you need it’ approach to CAR-T
Numerous academic medical centers around the world have demonstrated the ability to develop and produce safe and effective chimeric antigen receptor T-cell therapies.
CRISPR-edited CAR-T appears safe, effective for advanced large B-cell lymphoma
More than half of patients who received a single dose of CTX110 for relapsed or refractory large B-cell lymphoma responded to therapy, according to topline data released by the agent’s manufacturer.
CRISPR editing can produce ‘life-altering’ changes in patient health, Nobel laureate says
The CRISPR/Cas9 gene-editing system already is producing results that may fundamentally transform the treatment of certain diseases, according to one of the recipients of the 2020 Nobel Prize in Chemistry.
FDA places clinical hold on Allogene’s allogeneic CAR-T trials
The FDA placed a clinical hold on a series of clinical trials that use Allogene Therapeutics’ AlloCAR T chimeric antigen receptor T-cell therapies, according to a press release from the manufacturer.
FDA grants orphan drug designation to posoleucel for virus-associated hemorrhagic cystitis
The FDA granted orphan drug designation to posoleucel for the treatment of virus-associated hemorrhagic cystitis, according to the agent’s manufacturer.
Researchers ‘extraordinarily optimistic’ about potential of CAR-T for pediatric brain cancer
Brain and central nervous system tumors are the second most common malignancy among children and the most prevalent form of solid tumor, according to American Cancer Society data.
FDA approves Tecartus for B-cell precursor ALL
The FDA approved brexucabtagene autoleucel for treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.