Iovance submits EU marketing authorization for lifileucel for advanced melanoma

Source: Healio, July 2024

Iovance Biotherapeutics has submitted a marketing authorization application to the European Medicines Agency for lifileucel to treat advanced melanoma, the company announced in a press release.

Lifileucel is a tumor infiltrating lymphocyte cell therapy indicated for adults with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody. If approved, the drug will be the first and only therapy approved in this treatment setting in the European Union.

“This EU regulatory submission is the first step toward expanding lifileucel into global markets with a high prevalence of advanced melanoma,” Raj K. Puri, MD, PhD, Iovance executive vice president of regulatory strategy and translational medicine, said in the release.
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