At a July 2017 FDA Oncology Advisory Committee meeting, the panel reviewed Novartis’ CTL019 (tisagenlecleucel), an agent for aggressive pediatric and young adult acute B-cell acute lymphoblastic leukemia (ALL). The …
CAR T-Cell Therapy HCP Guide – Is CAR T-Cell Therapy Approved? Read More
CAR T-Cell FDA Approval: Status Update In addition to the approval of Kymriah, Yescarta (axicabtagene ciloleucel or Axi-Cel) was approved on October 18, 2017 for the treatment of adult patients …
CAR T-Cell Therapy HCP Guide – Updates from the FDA Read More
CAR T: Further Questions and Ongoing Research Scientists and clinicians alike are excited about this new therapy that may offer extended survival to certain patients who have exhausted their options …
CAR T-Cell Therapy HCP Guide – Further Questions and Ongoing Research Read More
The manufacturing process for CAR-T cells is similar, even though the design and structure of the tumor specific scFv (single chain fragment variable) may be proprietary. The methods used to …
CAR T-Cell Therapy HCP Guide – Quality and Education: Necessary Steps Read More
In the manufacturing facility the CAR structure is synthesized using the patient’s own T-cells. The CAR is a fusion protein that contains 3 distinct functional domains. For example, with axicabtagene …
CAR T-Cell Therapy HCP Guide – CAR Structure Read More
Before the bioengineered T-cells are reinfused, the patient undergoes a conditioning chemotherapy regimen to reduced the competing T-cell population (lymphodepletion), lower the tumor burden and help reduce serious complications such …
CAR T-Cell Therapy HCP Guide – Patient Delivery: The Preinfusion Conditioning Regime Read More
CAR T-cell therapy is not yet approved by the FDA and is considered investigational; a patient must enter a clinical trial to receive it. Here’s the process: Leukapheresis: The patient’s …
CAR T-Cell Therapy HCP Guide – How Are CAR T-Cells Manufactured? Read More
Axicabtagene ciloleucel (KTE-C19) from Kite Pharma was the first CAR T-cell therapy submitted to the FDA for approval in March 2017. For the current submission, axicabtagene ciloleucel has been studied …
CAR T-Cell Therapy HCP Guide – CAR T-Cell Therapy at the FDA Read More
Tumor lysis syndrome (TLS) is another known and expected side effect of CAR T-cell therapy. TLS occurs due to cell death and sunsequent release of content into the bloodstream. Multiple …
CAR T-Cell Therapy HCP Guide – Side Effects: Tumor Lysis Syndrome Read More
One of the advantages of CAR T-cell therapy that targets the C19 tumor antigen is that C19 is not found on other cells except B cells, sparing other healthy tissues. …
CAR T-Cell Therapy HCP Guide – Side Effects: B Cell Aplasia Read More