Yescarta (axicabtagene ciloleucel)
- Region
- 🇪🇺 EU
- Active substance
- axicabtagene ciloleucel
- Company
- Kite Pharma EU B.V.
- Status
- Authorised
- Therapeutic area
- Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
- CHMP opinion
- Thu 28 Jun 2018
- EU approval
- Thu 23 Aug 2018
- Designations
- Orphan, PRIME, ATMP, Additional monitoring
- Application
- EMEA/H/C/004480
- ATC
- L01XX70
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.