Yes, Kymriah is approved. It has received approval from the European Commission (EC) for specific indications.
Understanding Kymriah's Approval
Kymriah (tisagenlecleucel) is an innovative CAR-T cell therapy developed by Novartis. Its approval marks a significant step forward in the treatment of certain challenging cancers.
On May 4, 2022, the European Commission officially approved Kymriah for the treatment of adult patients diagnosed with:
- Relapsed or Refractory (r/r) Follicular Lymphoma (FL): Specifically for those who have undergone two or more lines of systemic therapy and whose disease has returned or not responded to previous treatments.
This approval highlights Kymriah's role as a targeted, personalized treatment option for patients with limited therapeutic alternatives.
Key Details of Kymriah's EC Approval
To provide a clear overview, here are the essential details regarding the European Commission's approval of Kymriah:
| Aspect | Detail |
|---|---|
| Therapy Name | Kymriah® (tisagenlecleucel) |
| Therapy Type | CAR-T cell therapy |
| Developer | Novartis |
| Approving Body | European Commission (EC) |
| Approval Date | May 4, 2022 |
| Indication | Adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy |
This approval by the EC signifies that Kymriah has met the stringent regulatory standards for safety, efficacy, and quality within the European Union, offering a new treatment pathway for eligible patients.
For further information regarding the approval, you can refer to the official media release from Novartis: Novartis Kymriah® receives EC approval as first CAR-T cell therapy...
