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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Follicular Lymphoma |
| Drug: | Kymriah (tisagenlecleucel-T) (CD19-targeted CAR-T immunotherapy) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
FDA approves Novartis Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma
Published date:
05/28/2022
Excerpt:
Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah® (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy... Prolonged durable response to treatment was demonstrated with an estimated 85% of patients who achieved a complete response still in response 12 months after initial response1. Kymriah was shown to be effective in high-risk patients including those who were heavily pretreated or had refractory disease, POD24, bulky disease or those with high Follicular Lymphoma International Prognostic Index (FLIPI) scores1.
Source:
Title:
Novartis Kymriah® receives EC approval as first CAR-T cell therapy for adults with relapsed or refractory follicular lymphoma
Published date:
05/04/2022
Excerpt:
Novartis announced today that the European Commission (EC) has approved Kymriah® (tisagenlecleucel), a CAR-T cell therapy, for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.
Source:
Excerpt:
Follicular Lymphoma: Suggested treatment regimens…Anti-CD19 CAR T-cell therapy (only after ≥2 prior chemoimmunotherapy regimens…Tisagenlecleucel
Source:
Title:
Novartis receives priority review by US FDA and filing acceptance by EMA for Kymriah® to treat patients with relapsed or refractory follicular lymphoma
Published date:
10/27/2021
Excerpt:
Novartis today announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted the company’s Supplemental Biologics License Application (sBLA)...The FDA has also granted priority review to the company’s sBLA for Kymriah in adult patients with r/r FL.
