Gilead's Tecartus gets EMA panel backing for expanded use in blood cancer subtype
Waldemarus


A committee of the European Medicines Agency (EMA) recommended the expanded approval of Gilead Sciences' (NASDAQ:GILD) CAR T cell therapy Tecartus to treat adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).

Gilead's unit Kite had received conditional authorization in EU for Tecartus (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19) in December 2020 to treat certain patients with mantle cell lymphoma.
The European Commission (EC) will make a final decision on the positive opinion issued by the EMA's Committee for Medicinal Products for Human Use. The EC generally follows the recommendation of the EMA on whether to approve a drug.