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(RTTNews) - Iovance Biotherapeutics (IOVA) submitted a marketing authorization application to the European Medicines Agency for lifileucel, a TIL cell therapy, for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. The MAA submission is supported by positive clinical data from the C-144-01 clinical trial in patients with advanced post-anti-PD1 melanoma.
The company noted that, if approved, lifileucel will be the first and only approved therapy in this treatment setting in all European Union member states.
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