CAR T cell therapy receives approval for use across European Union

The European Commission (EC) has approved a personalized cellular therapy developed at the Abramson Cancer Center, making it the first CAR T cell therapy permitted for use in the European Union in two distinct indications. The EC granted the approval to Novartis for Kymriah® (tisagenlecleucel, formerly CTL019) for the treatment of a select form of leukemia in pediatric and young adult patients, and a particular form of lymphoma in patients over 18.

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Folks from the Abramson Cancer Center celebrate Kymriah’s initial approval by the U.S. Food and Drug Administration in August 2017.

“This is another milestone in the fight against cancer, allowing patients across the European Union to benefit from these potentially lifesaving therapies,” said Carl June, an immunotherapy professor in the department of pathology and laboratory medicine in the Perelman School of Medicine, and director of the Center for Cellular Immunotherapies at the Abramson Cancer Center. “This approval demonstrates the global impact of the therapies we developed in Philadelphia, and the far-reaching potential of these therapies to change the way cancer is treated across the world.”

Investigators at Penn’s Perelman School of Medicine led research, development, and clinical trials of CAR T therapy in collaboration with Novartis and the Children’s Hospital of Philadelphia. In August 2017, Kymriah became the first therapy based on gene transfer ever approved by the FDA when it was authorized for children and young adults with a specific leukemia: relapsed or refractory B-cell ALL. Approval for lymphoma characterized as relapsed or refractory DLBCL followed in May 2018.

The treatment modifies patients’ own immune T cells, which are collected and reprogrammed at the Novartis manufacturing facility to potentially seek and destroy the patients’ cancer cells. Once they are infused back into patients’ bodies, these newly built cells both multiply and attack, targeting cells that express a protein called CD19. Tests reveal the army of hunter cells can grow to more than 10,000 new cells for each single engineered cell patients receive, and can survive in the body for years.

The approval in the EU is the latest accomplishment in the alliance between Penn and Novartis, which entered into a global collaboration in 2012 to further research, develop, and commercialize Kymriah and other CAR T-cell therapies for the treatment of cancers.

Read more at Penn Medicine News.