EU approves Yescarta for relapsed or refractory follicular lymphoma.- Kite Pharma
Kite Pharma announced that the European Commission (EC) has approved its CAR T-cell therapy Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.
Yescarta has maintained orphan medicinal product designation in this indication.
The approval is supported by data from the pivotal, single-arm Phase II ZUMA-5 international study in patients with relapsed or refractory FL who had received at least two prior lines of systemic therapy, including the combination of an anti-CD20 monoclonal antibody and an alkylating agent. Among patients who had received three or more lines of prior therapy (n=75), the overall response rate (ORR) was 91%, and the complete response (CR) rate was 77% at the 24-month analysis. The median duration of response (DoR) was 38.6 months, and the proportion of responders still in response at Month 24 was 56%.
Among all evaluable patients within ZUMA-5 (n=119), safety observations were consistent with the known safety profile for Yescarta. Grade more than 3 cytokine release syndrome (CRS) occurred in 6% of patients and neurologic events occurred 16% of patients. Most CRS cases (99%) of any grade resolved by the time of data cut-off and 60% of neurologic events were resolved within three weeks. The most significant and frequently occurring adverse events were CRS (77%), infections (59%) and encephalopathy (47%). For full details on the Special Warnings and Precautions for Use and Adverse Reactions (including appropriate management), please refer to the EU Summary of Product Characteristics (SmPC). Additional data were shared separately during an oral presentation at the 2021 American Society of Hematology Meeting.
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