The Committee for Medicinal Products for Human Use (CHMP) has announced that two products have been recommended for use in Europe: Kymriah (tisangenlecleucel) and Yescarta (axicabtagene ciloleucel). These are the first two chimeric antigen receptor (CAR) T-cell products to receive approval, and work to treat cancer by obtaining and modifying the patient’s immune cells.
CHMP were informed by opinions from the Committee for Advanced Therapies (CAT), as both products are advanced therapy medicinal products (ATMPs). The chair of CAT, Dr Martina Schüssler-Lenz said,
“CAR-T cells transform the fight against serious and often fatal diseases in the EU. Kymriah and Yescarta offer an innovative approach where patients’ cells are reprogrammed and reinjected to attack the cancer.”
These products also represent the first CHMP recommendations for products supported by PRIME (the EMA’s PRIority MEdicines scheme), demonstrating the success of the integration of different levels of EMA assessment and support.
To read more on the story, and consequences of the CHMP recommendation, click here.