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Congratulations to IO360° Speaker Dr Jeff Legos and His Team at Novartis for the Early Approval for a New CAR-T Therapy to Treat ALL
September 1, 2017
Congratulations to IO360° speaker Dr Jeff Legos and his team at Novartis for the early approval of Kymriah (tisagenlecleucel), the first CAR-T therapy to enter the market to treat acute lymphoblastic lymphoma. This has been recognized as a historic event by regulators.
“We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA commissioner, Scott Gottlieb. “New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses. At the FDA, we’re committed to helping expedite the development and review of groundbreaking treatments that have the potential to be life-saving.”
The first pediatric patient to ever undergo CAR-T therapy for ALL was Emily Whitehead, who received the treatment by CAR-T pioneer, Dr Carl June and his team at the Children’s Hospital of Philadelphia (CHOP). Emily and her parents, Tom and Kari Whitehead, joined IO360° 2016 to share the journey through the immunotherapy trial. Emily is now 5 years cancer-free and was present at the FDA advisory hearing in July, where the panel unanimously recommended that the agency approve the treatment. The early approval of Kymriah comes about a month ahead of the PDUFA date.
Dr Legos recently spoke at the IO360° 2017 program on integrating immune-oncology into cancer modalities. The next IO360° summit is on February 7-9, 2018 in NYC and includes a talk on “Target Discovery for CAR-Ts and TCRs” during the Discovery & Preclinical plenary session.