First CAR T-Cell Therapies OK'd In EU: Novartis's Kymriah And Kite's Yescarta
The European Medicines Agency's drug evaluation committee, the CHMP, has recommended nine products for marketing authorization in the EU, including the first two CAR T-cell therapies, Novartis's Kymriah and Kite Pharma's Yescarta, as well as four other orphan drugs.
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A product that was initially turned down for marketing approval in the EU has now been given the green light for use on the National Health Service in Scotland, following a similar recommendation in England late last year.
CBER director says lack of a clear regulatory structure is holding back the development and acceleration of gene therapy products, while industry says regulations should be flexible to keep up with changing technology for these products.
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.