Positive FDA Feedback Supports BLA Submission for Lifileucel in Melanoma

Source: OncLive, April 2022

The FDA has provided positive feedback regarding Iovance Biotherapeutics, Inc.’s proposed matrix of potency assays for an upcoming biologics license application (BLA) seeking the approval of lifileucel (LN-144) in the treatment of patients with metastatic melanoma.

Based on this response, the company shared plans to request a pre-BLA meeting in July 2022 to complete the submission of the application by August 2022.

“The favorable feedback received from the FDA on our potency assays and assay matrix brings Iovance a step closer to our submission of a BLA for lifileucel in metastatic melanoma,” Frederick Vogt, PhD, JD, interim president and chief executive officer of Iovance Biotherapeutics, Inc., stated in a press release. “We look forward to bringing lifileucel to the market quickly to offer [patients with] melanoma a new option following anti–PD-1 therapy.”