Gilead Sciences subsidiary Kite has secured a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the use of Yescarta (axicabtagene ciloleucel) to treat adults with certain forms of B-cell lymphoma.
The drug’s marketing authorisation application (MAA) is seeking approval for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), following two or more lines of systemic therapy.
Yescarta is a chimeric antigen receptor T cell (CAR T) therapy designed to alter patient’s own T cells to identify and attack cancer cells.
It is said to have the potential to trigger complete responses in a select patient population suffering from aggressive non-Hodgkin lymphoma (NHL).
Gilead oncology therapeutics executive vice-president and cell therapy head Alessandro Riva said: “This CHMP positive opinion is an important milestone for those patients in the European Union living with DLBCL or PMBCL.
“The recommendation brings axicabtagene ciloleucel one step closer to adult patients who currently have few or no treatment options available to them and we are focused on providing access to this innovative treatment as quickly as possible.”
Yescarta’s application to the EMA includes results from the single-arm ZUMA-1 trial that was conducted in adult subjects with refractory aggressive NHL.
Findings revealed 72% of participants treated with a single infusion of axicabtagene ciloleucel responding to therapy, of which 51% achieved a complete response.
Cytokine release syndrome (CRS), neurologic events and cytopenias were some of the grade 3 or higher adverse events observed in the ZUMA-1 trial.
Axicabtagene ciloleucel obtained PRIME status from the EMA in May 2016 and the US Food and Drug Administration (FDA) approval last October.