Car T-Cell Therapy

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.

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.

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.

Numerous academic medical centers around the world have demonstrated the ability to develop and produce safe and effective chimeric antigen receptor T-cell therapies.

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.

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.

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.

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.

The FDA approved brexucabtagene autoleucel for treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Kite Pharma submitted a supplemental biologics license application to the FDA that seeks expanded approval of axicabtagene ciloleucel.