Basic Information
Yescarta
Regulatory Information
EMEA/H/C/004480
August 23, 2018
June 28, 2018
17
August 16, 2024
Company Information
the netherlands
Tufsteen 1 2132 NT Hoofddorp
Kite Pharma EU BV
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Yescarta is indicated for the treatment of adult patients with diffuse large B cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. Yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) DLBCL and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy. Yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (FL) after three or more lines of systemic therapy.
Overview Summary
Yescarta is a medicine for treating adults with certain types of blood cancer: - high-grade B-cell lymphoma (HGBL); - diffuse large B-cell lymphoma (DLBCL); - primary mediastinal large B-cell lymphoma (PMBCL); - follicular lymphoma (FL). Yescarta is for use in patients whose blood cancer has returned (recurrent) or has stopped responding to previous treatment (refractory). Yescarta is a type of advanced therapy medicine called a ‘gene therapy product’. This is a type of medicine that works by delivering genes into the body. The blood cancers that Yescarta is used to treat are rare, and Yescarta was designated an ‘orphan medicine’ (a medicine used in rare diseases) for DLBCL on [16 December 2014](/en/medicines/human/orphan-designations/eu-3-14-1393), for PMBCL on [9 October 2015](/en/medicines/human/orphan-designations/eu-3-15-1553) and for FL on [11 November 2015](/en/medicines/human/orphan-designations/eu-3-15-1579). Yescarta contains the active substance axicabtagene ciloleucel (consisting of genetically modified white blood cells).