A Massive First For EU – CAR-T Therapies Kymriah and Yescarta Hoping For CHMP OK
Six orphan drugs – including the first two CAR-T cell therapies in the EU – may get the green light from the European Medicines Agency at its June meeting this week. Will the negative opinion handed down earlier this year on Puma Biotechnology’s Nerlynx be overturned, though?
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The European Medicines Agency will begin a pilot in 2021 to examine the practical aspects of undertaking patient-level data assessments during medicines evaluation and identify scenarios when such assessments might be useful.
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.
With Novartis’s and Kite’s CAR T-cell therapies both expected to gain recommendations for pan-EU approval this week, discounts will need to be negotiated for these new treatments to reach the markets in Europe.