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Novartis’ CAR-T Therapy Kymriah Receives EC Approval

Continues strategy to expand mfg. facilities with agreements with external collaborators

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The European Commission (EC) has approved Novartis’ Kymriah (tisagenlecleucel) for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Kymriah, developed in collaboration with the University of Pennsylvania (Penn), is a one-time treatment that uses a patient’s own T cells to fight cancer, and the only chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval in the EU for these two distinct B-cell malignancies. Kymriah was also the first CAR-T cell therapy ever approved by the U.S. FDA.

“The Kymriah approval is a transformational milestone for patients in Europe in need of new treatment options,” said Liz Barrett, chief executive officer, Novartis Oncology. “Novartis will continue to build a global infrastructure for delivering CAR-T cell therapies where none existed before   remaining steadfast in our goal of reimagining cancer.”

Novartis expects to launch initially in the pediatric ALL indication, as it continues to ramp up capacity. As the treatment is made available to more patients globally, Novartis says is has been actively pursuing options to expand manufacturing capabilities beyond its facility in Morris Plains, NJ. This includes an agreement with CELLforCURE, based in France and one of the first and largest contract development and manufacturing organizations (CDMOs) producing cell and gene therapies in Europe, the expanded alliance with Fraunhofer Institute, which currently supports the manufacturing of Kymriah for global clinical trials and for post approval manufacturing, as well as technology transfer efforts to a CDMO in Japan.

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