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CAR T-Cell Therapy HCP Guide – Is CAR T-Cell Therapy Approved?
At a July 2017 FDA Oncology Advisory Committee meeting, the panel reviewed Novartis’ CTL019 (tisagenlecleucel), an agent for aggressive pediatric and young adult acute...
CAR T-Cell Therapy HCP Guide – Updates from the FDA
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,...
CAR T-Cell Therapy HCP Guide – Further Questions and Ongoing Research
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...
CAR T-Cell Therapy HCP Guide – Quality and Education: Necessary Steps
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...
CAR T-Cell Therapy HCP Guide – CAR Structure
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...
CAR T-Cell Therapy HCP Guide – Patient Delivery: The Preinfusion Conditioning Regime
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...
CAR T-Cell Therapy HCP Guide – How Are CAR T-Cells Manufactured?
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....
CAR T-Cell Therapy HCP Guide – CAR T-Cell Therapy at the FDA
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...
CAR T-Cell Therapy HCP Guide – Side Effects: Tumor Lysis Syndrome
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...
CAR T-Cell Therapy HCP Guide – Side Effects: B Cell Aplasia
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...
