The first chimeric antigen receptor (CAR) T-cell therapy has been approved by the FDA for use in relapsed/refractory leukemia, for which it offers a 'paradigm shift.'
The US Food and Drug Administration (FDA) has approvedbrexucabtagene autoleucel(Tecartus) for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursoracute lymphoblastic leukemia (ALL). The therapy is the first chimeric antigen receptor (CAR) T-cell tre...
The FDA gave the green light to Novartis's tisagenlecleucel for the treatment of acute lymphoblastic leukaemia (ALL), marking a historic approval for a first-in-modality chimeric antigen receptor (CAR) T cell therapy. CAR Ts are an ex vivo form of gene therapy, in which T cells are rem...
TheCAR-T cell treatment developed by Novartisand the University of Pennsylvania is the first type ofgene therapyto hit the U.S. market — and one in a powerful but expensive wave of custom-made "living drugs" being tested againstblood cancersand some other tumors, too. FDA called the appro...
The article reports on the clinical trial that will be launched by Bioheart to test a combination gene and stem cell therapy for congestive heart failure (CHF). According to Bioheart, a phase I trial for Myocell Stroma Derived Factor-1 (SDF-1) to treat CHF has been approved by the U....
Officials with the FDA approved idecabtagene vicleucel (Abecma, Bristol Myers Squibb) for the treatment of relapsed or refractory multiple myeloma after 4 or more prior lines of therapy. It is the first-in-class B-cell maturation agent (BCMA)-directed personalized immune ...
Fosun Kite Biotech was founded in 2017 in Shanghai, aiming to develop immune cell therapy products. Yescarta is its first commercialized product. The FDA approved Yescarta for treating adults with certain types of large B-cell lymphoma in the US in October 2017,the first approval for this produ...
On Fubruary 16th, U.S. Food and Drug Administration (FDA) has approved Amtagvi, marking the first instance where a cell therapy has been authorized for the
Officials with the FDA have approved capmatinib (Tabrecta, Novartis Pharmaceuticals) for the treatment of adult patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Capmatinib is the first FDA-approved therapy to treat NSCLC with specific mutations (those ...
Abecma (idecabtagene vicleucel), a chimeric antigen receptor (CAR) T-cell therapy, was approved by the U.S. Food and Drug Administration for the treatment of multiple myeloma, the agency announced Saturday.