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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Title:

Kite’s Tecartus™ (KTE-X19) Granted Conditional Marketing Authorization for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma in Europe

Published date:
12/16/2020
Excerpt:
Kite, a Gilead Company (Nasdaq: GILD), today announced that the European Commission has granted conditional marketing authorization for Tecartus™ (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19). Tecartus is a chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.
Evidence Level:
Sensitive: A1 - Approval
Published date:
12/14/2020
Excerpt:
Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.
Evidence Level:
Sensitive: A1 - Approval
Source:
Title:

FDA Approves First Cell-Based Gene Therapy For Adult Patients with Relapsed or Refractory MCL

Published date:
07/24/2020
Excerpt:
...the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment. Tecartus, a chimeric antigen receptor (CAR) T cell therapy, is the first cell-based gene therapy approved by the FDA for the treatment of MCL.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:

NHS patients to benefit from first full access deal in Europe for new CAR-T therapy recommended by NIC

Published date:
01/19/2021
Excerpt:
Tecartus also known as autologous anti-CD19-transduced CD3+, is a CAR-T therapy...New NICE guidance issued today (Tuesday 19 January 2021) says the treatment can be considered for those with relapsed or refractory mantle cell lymphoma, who must previously have had a drug called Bruton’s tyrosine kinase (BTK) inhibitor, such as ibrutinib.
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
Mantle cell lymphoma: Useful in Certain Circumstances…Brexucabtagene autoleucel (only given after chemoimmunotherapy and BTK inhibitor)