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Kite's CAR T-cell Therapy Tecartus Gets Positive CHMP Opinion In Acute Lymphoblastic Leukemia

Kite, a Gilead Co. (GILD), said Friday that the European Medicines Agency or EMA Committee for Medicinal Products for Human Use or CHMP has issued a positive opinion for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and above with relapsed or refractory or r/r B-cell precursor acute lymphoblastic leukemia or ALL.

Acute Lymphoblastic Leukemia is an aggressive type of blood cancer that develops when abnormal white blood cells accumulate in the bone marrow until there isn't any room left for blood cells to form. In some cases, the abnormal cells invade healthy organs and can also involve the lymph nodes, spleen, liver, central nervous system and other organs. The most common form is B cell precursor acute lymphoblastic leukemia.

If approved, Tecartus will be the first and only Chimeric Antigen Receptor (CAR) T-cell therapy for this population of patients who have limited treatment options. Half of adults with ALL will relapse, and median overall survival (OS) for this group is only approximately eight months with current standard-of-care treatments.

Following the positive opinion, the European Commission will now review the CHMP opinion; the final decision on the Marketing Authorization is expected in the coming months.

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