Cell Therapy News

The FDA cleared investigational new drug applications for three cell therapies in development for oncology indications.

Faith E. Davies, MD, has been appointed the inaugural director of Center for Blood Cancers at NYU Langone Health’s Perlmutter Cancer Center.

BioCardia announced the FDA has granted breakthrough device designation to its cell therapy system for the treatment for HF.

The FDA updated the prescribing information for axicabtagene ciloleucel to allow the use of prophylactic corticosteroids to manage the severity of certain treatment-related adverse events.

Clinicians who treat patients with chimeric antigen receptor T cells have become adept at identifying and treating acute neurotoxicity, a common adverse event associated with the therapy.

B-cell acute lymphoblastic leukemia is the most common type of cancer among children.

Prior treatment with newer-generation therapies appeared associated with significantly lower objective response rates among patients who received tumor-infiltrating lymphocytes for metastatic melanoma, according to study findings.

The FDA granted orphan drug designation to CNCT19, a chimeric antigen receptor T-cell therapy for the treatment of relapsed or refractory acute lymphoblastic leukemia.

The FDA granted fast track designation to CYNK-101, a natural killer cell-based therapy for treatment of advanced HER2/neu-positive gastric or gastroesophageal junction adenocarcinoma.

The FDA granted fast track and regenerative medicine advanced therapy designations to C-CAR039, a chimeric antigen receptor T-cell therapy in development for treatment of relapsed or refractory diffuse large B cell lymphoma.