The European Commission (EC) has authorized approval for CAR-T cell therapy by Novartis, Kymriah (tisagenlecleucel), for the treatment of adults with recurrent or refractory (r / r) follicular lymphoma (FL).

Kymriah is indicated for patients with r / r FL after two or more lines of systemic therapy.

The latest approval comes after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a favorable opinion in March this year.

This cell therapy can be used in all 27 EU Member States, as well as in Iceland, Norway and Liechtenstein with the latest developments.

The EC has approved Kymriah’s ELARA Phase II international clinical trial.

In the study, 86% of subjects in Kymriah’s arm showed a response, while 69% of them found a complete response (CR).

In addition, a sustained and long-term response to therapy was observed in almost 87% of subjects who achieved CR still in response to or over nine months after the previous response.

The safety profile of Kymriah in the study was remarkable with the cytokine release syndrome (CRS) observed in 50% of subjects after infusion of cell therapy.

Marie-France Chudin, President and Chief Commercial Officer of Novartis Innovative Medicines International, said: “With this approval, we are pleased to be able to offer this transforming therapy to more people around the world living with this advanced blood cancer.

“With long-term responses and a safety profile that allows for flexible administration, we strive to rewrite cancer survival and alleviate the severity of this disease for patients and the health care system.

The latest approval for the treatment of r / r FL is Novartis’ third indication for Kymriah in the EU.

Cell therapy has already been approved for the treatment of pediatric and young adults up to 25 years of age, including B-cell acute lymphoblastic leukemia and for adults with r / r diffuse large cell lymphoma.

In April 2020, the US Food and Drug Administration provided Kymriah’s Advanced Regenerative Medicine Indication for r / r FL.

The coverage for cell and gene therapy in pharmaceutical technology is maintained by Cytiva.

Editorial content is produced independently and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.

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