From their meeting in June, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
At this meeting there were nine recommendations for approvals of medicines, including the first two chimeric antigen receptors (CAR) T-cell therapies in the European Union; Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) are both advanced therapy medicinal products (ATMPs) intended for the treatment of certain blood cancers. Kymriah and Yescarta were designated as orphan medicines during their development. They are also the first medicines supported through EMA’s PRIority MEdicines (PRIME) scheme to receive a positive opinion from the Committee. Six orphan medicines were also recommended for approval.
The CHMP recommended granting a marketing authorisation for Nerlynx (neratinib), for the adjuvant treatment of adult patients with breast cancer, after re-examining its negative opinion for this medicine adopted in February 2018. There was also seven recommendations on extensions of therapeutic indications for Dexdor, Inovelon, Jinarc, Lenvima, Opdivo, Rapamune and RoActemra.
For the meeting summary, and a full list of approvals, opinions and withdrawals, please click here.