Novartis receives European Commission approval of its CAR-T cell therapy, Kymriah (tisagenlecleucel)
- The EC approval is based on the first global CAR-T?registration?trials, which included patients from eight European countries and demonstrated durable responses and a consistent safety profile in r/r pediatric B-cell ALL?and r/r?DLBCL
- Novartis is the only company with an approved CAR-T cell therapy for pediatric r/r B-cell ALL and the first to receive approval in two distinct indications, both in the EU and the US
- Novartis continues its strategy to expand manufacturing facilities with agreements with external?collaborators, such as CELLforCURE?in France
- Unresolved serious adverse reactions (especially pulmonary reactions, cardiac reactions or hypotension) from preceding chemotherapies.
- Active uncontrolled infection.
- Active graft-versus-host disease (GVHD).
- Significant clinical worsening of leukemia burden or lymphoma following lymphodepleting chemotherapy.
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Novartis Media Relations Central media line: +41 61 324 2200 E-mail:?media.relations@novartis.comEric Althoff Novartis Global Media Relations +41 61 324 7999 (direct) +41 79 593 4202 (mobile) eric.althoff@novartis.com | Fiona Phillips Novartis Oncology Communications +1 862-778-7705 (direct) +1 862-217-9396 (mobile) fiona.phillips@novartis.com |
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