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jondoeuk

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jondoeuk

Re: None

Friday, 04/08/2022 3:04:20 PM

Friday, April 08, 2022 3:04:20 PM

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The company has received positive feedback from the FDA on both its potency assay matrix and its proprietary cell co-culture assay. Based on this response, they expect to request a pre-BLA meeting in July and to complete a BLA submission for lifileucel by August. In addition, plan to open a PhIII trial for lifileucel in combination with pembro for the treatment of immune checkpoint inhibitor naïve front-line metastatic melanoma in late 2022.
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