Kymriah (tisagenlecleucel)
- Region
- 🇪🇺 EU
- Active substance
- tisagenlecleucel
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse
- CHMP opinion
- Wed 27 Jun 2018
- EU approval
- Thu 23 Aug 2018
- Designations
- Orphan, PRIME, ATMP, Additional monitoring
- Application
- EMEA/H/C/004090
- ATC
- L01XL04
- Official record
- www.ema.europa.eu
Indication
Kymriah is indicated for the treatment of: • Paediatric and young adult patients up to and including 25 years of age with B cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post transplant or in second or later relapse. • Adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy. • Adult patients with relapsed or refractory follicular lymphoma (FL) after two 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.