09:44 AM EDT, 06/28/2024 (MT Newswires) -- Iovance Biotherapeutics ( IOVA ) said Friday it has applied for marketing authorization from the European Medicines Agency for lifileucel, which is intended for the treatment of adults with advanced melanoma.

The company said the application is supported by positive clinical data from a trial in patients with advanced post-anti-PD1 melanoma.

The application is expected to be validated in Q3, after which the Committee for Medicinal Products for Human Use is anticipated to issue a scientific opinion for the European Commission to adopt in 2025, the company said.

Iovance said additional marketing submissions for the drug candidate are expected in Canada and the UK in the second half of 2024 and in Australia in 2025.

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