First two CAR-T cell therapies among latest EMA/CHMP recommendations

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval, including six orphan medicines, and two CAR-T therapies, at its June 2018 meeting.

The CHMP recommended granting marketing authorizations for the first two CAR-T cell therapies in the European Union: Kymriah (tisagenlecleucel), from Novartis (NOVN: VX), and Yescarta (axicabtagene ciloleucel), from Kite, a Gilead Sciences (Nasdaq: GILD) company, 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. The voluntary scheme provides early and enhanced scientific and regulatory support to medicines that have the potential to address, to a significant extent, patients’ unmet medical needs. Kymriah was granted eligibility to PRIME on June 23, 2016, for the treatment of acute lymphoblastic leukemia (ALL). Yescarta was granted eligibility to PRIME on May 26, 2016, for the treatment of diffuse large B-cell lymphoma (DLBCL).