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Novartis’ Kymriah Wins FDA Approval as First CAR-T Cancer Therapy

The FDA today approved Novartis’ Kymriah (tisagenlecleucel), with the agency hailing the chimeric antigen receptor T-cell (CAR-T) treatment as the first gene therapy to be available in the U.S.

“This therapy is a significant step forward in individualized cancer treatment that may have a tremendous impact on patients’ lives,” Carl June, M.D., the leader of the Penn team, said in Novartis’ statement. Dr. June is the Richard W. Vague Professor of Immunotherapy, director of the Center for Cellular Immunotherapies in Penn’s Perelman School of Medicine and director of the Parker Institute for Cancer Immunotherapy at Penn.

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