The EC approval is supported by the Phase 2 ELARA trial, which showed that Kymriah has resulted in superior response rates in pre-treated patients
Novartis Banting 1 laboratory. (Credit: Novartis AG)
Novartis has received the European Commission (EC) approval for Kymriah (tisagenlecleucel) to treat relapsed or refractory (r/r) follicular lymphoma (FL) in adults.
Kymriah is a CAR-T cell therapy, previously approved in Europe for B cell acute lymphoblastic leukaemia (ALL) and diffuses large B cell lymphoma (DLBCL) indications.
The current approval marks the third indication for Kymriah and is the first CAR-T cell therapy approved in the EU for FL patients, with r/r FL grade 1, 2 and 3A1.
It follows a positive recommendation by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), granted in March.
The EC approval was supported by the Phase 2 ELARA trial, which showed that 86% of patients treated with Kymriah had a response, whereas 69% of them had a complete response (CR).
The prolonged durable response to treatment was determined with an estimated 87% of patients who achieved a CR at or more than nine months after initial response.
Novartis said that Kymriah showed a remarkable safety profile, with Cytokine release syndrome (CRS) reported in 50% of patients, and no Grade 3 or 4 events reported.
With the EC approval, the Swiss drugmaker can commercialise Kymriah for this indication, in all 27 European Union (EU) member states, along with Iceland, Norway and Liechtenstein.
Novartis innovative medicines international and chief commercial officer president Marie-France Tschudin said: “With this approval, we are pleased to be able to offer this transformative therapy to more people across the globe living with this advanced blood cancer.
“With long-lasting responses and a safety profile that allows for flexible administration, we are striving to rewrite cancer survival and alleviate the burden of this disease for patients and the healthcare system.”
In a separate development, Novartis has unveiled positive median overall survival (OS) results for Kisqali (ribociclib) plus fulvestrant, from the Phase 3 MONALEESA-3 study.
The analysis included patients first-line subgroup of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
In the analysis, treatment using Kisqali plus fulvestrant showed a significant OS benefit of nearly 16 months compared to the treatment using fulvestrant alone.
Furthermore, a final OS analysis showed statistically significant OS benefit for Kisqali plus fulvestrant combination and 28% reduction in risk of death compared to fulvestrant alone.