Categorized | Melanoma In The News, FDA

FDA Grants LN-144 Fast Track Status for Melanoma

Source: OncLive, September 2017

The FDA has granted LN-144, an adoptive cell therapy that uses tumor-infiltrating lymphocyte (TIL) technology developed by Iovance Biotherapeutics, a fast track designation for the treatment of patients with advanced melanoma.

The designation is based on data Iovance submitted from C-144-01, a phase II multicenter study. Efficacy data for 14 of the 16 patients who were treated showed that LN-144 induced an overall response rate (ORR) of 29% (n = 4). Researchers observed tumor reduction in 77% of patients.

The purpose of the FDA’s fast track designation is to accelerate the development and regulatory review of drugs intended to treat serious conditions and fill an unmet medical need. The designation allows for a rolling review of a company’s biologic license application.

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