FDA Accepts Novartis’ Application for New Indication for Kymriah
Novatis is seeking approval for Kymriah in adult patients with advanced follicular lymphoma.
The FDA has accepted Novartis’ supplemental biologics license application (sBLA) and for Kymriah (tisagenlecleucel) in adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two prior lines of treatment. The agency has also granted priority review for this application.
If approved, this would be the third indication for Kymriah, which is an autologous, immunocellular cancer therapy that involves reprogramming a patient's own T-cells with a chimeric antigen receptor (CAR) to identify and eliminate CD19-expressing cells. It is administered as intravenous infusion.
The submission is based on positive data from the pivotal phase 2 ELARA trial, which investigated the efficacy and safety of Kymriah in adult patients with r/r FL. The trial met the primary endpoint with robust responses observed in heavily pretreated patients. The majority of patients treated (66%) achieved a complete response; the overall response rate was 86%.
In the trial, no patients experienced grade 3 or higher cytokine release syndrome related to Kymriah within the first eight weeks following infusion.
Novartis also submitted an application for this indication to the European Medicines Agency. The European Commission has granted Kymriah an orphan drug designation for relapsed or refractory follicular lymphoma.
Kymriah is currently approved by the FDA, EMA and other regulatory authorities for the treatment of r/r pediatric and young adult (up to and including 25 years of age) acute lymphoblastic leukemia, and r/r adult diffuse large B-cell lymphoma.
Follicular lymphoma is the second most common form of non-Hodgkin lymphoma and represents about 22% of non-Hodgkin lymphoma cases.
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