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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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.
J&J is hoping its experimental new drug for treatment-resistant depression will join the select group of products benefitting from speedy review in the EU.