EU CAR-T Race Tightens After Yescarta Reverts To Standard Review
Kite and Novartis are vying to be the first company to have a CAR-T therapy approved in the EU. Both companies are hoping to be able to treat patients with r/r DLBCL.
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KTE-X19, Kite’s potential new CAR-T therapy, will in the end be fast-tracked at the European Medicines Agency. Lilly failed to secure the speedy review it was seeking for selpercatinib
New approvals in the EU were again dominated by oncology drugs in 2018, although medicines for infectious diseases were a close second. The number of orphan drugs more than doubled over the previous year, to 17. There were also some star arrivals in multiple sclerosis, genetic disorders, metabolism and migraine.
Building manufacturing capacity, educating physicians, and reaching agreements with pricing and reimbursement bodies are just some of the hurdles CAR-T therapies have to jump over in Europe, following their approval by the EU Commission earlier this week.