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Gilead's Tecartus Gets EMA CHMP Recommendation in Advanced ALL

NEW YORK – The European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday recommended approval for Gilead Sciences' autologous CAR T-cell therapy Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The European Commission will now decide whether to follow CHMP's recommendation and approve Tecartus for patients in the EU.

The recommendation is based on the results of the Phase I/II ZUMA-3 clinical trial, in which, after a median follow-up of 26.8 months, 71 percent of evaluable patients treated with Tecartus experienced a complete remission or complete remission with incomplete hematological recovery. Among a group of patients who received the pivotal dose, the median overall survival time was 25.4 months. For the patients who achieved a complete remission or complete remission with incomplete hematological response, the median overall survival time was 47 months. The median duration of remission was 18.6 months for all patients in the efficacy evaluable population.

Twenty five and 32 percent of patients, respectively, experienced grade 3 or higher cytokine release syndrome or neurological events after treatment, though Gilead said in a statement that toxicities on Tecartus were generally manageable.

CHMP's positive recommendation follows the US Food and Drug Administration's Tecartus approval in the same patient population last fall.

Both the FDA and EC have already approved the autologous cell therapy for mantle cell lymphoma. The treatment, which is a product of Gilead subsidiary Kite Pharma, involves harvesting a patient's immune cells, engineering them to target CD19 on the surface of cancer cells, and reinfusing them as a one-time treatment following lymphodepleting chemotherapy.