Iovance submits EU marketing authorization for lifileucel for advanced melanoma

Key takeaways:

• If approved, lifileucel will be the first in its therapy class for this indication.
• The application is supported by clinical trial data results where patients had a 31.5% objective response rate.

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.

The application is supported by results from the C-144-01 clinical trial, which found patients treated with lifileucel showed a 31.5% objective response rate.

The FDA granted accelerated approval to lifileucel, which is marketed in the U.S. under the name Amtagvi, in February.

The company is also planning submissions for approval in Canada, the United Kingdom and Australia.