The first real-time, non-invasive skin cancer evaluation system, which can detect basal cell carcinoma, melanoma, and squamous cell carcinoma, has been granted clearance by the FDA, according to a press release from DermaSensor Inc.
Regulatory
FDA Grants Accelerated Approval to Lifileucel for Unresectable or Metastatic Melanoma
On February 16, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lifileucel (Amtagvi), a tumor-derived autologous T-cell immunotherapy, for adult patients with unresectable or metastatic melanoma who were previously treated with a PD-1 blocking antibody, or, if they have BRAF V600 mutation–positive disease, a BRAF inhibitor with or without a MEK inhibitor.
C-144-01 Trial
FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma
Today, the U.S. Food and Drug Administration approved Amtagvi (lifileucel), the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor).
FDA Approves Lifileucel for Unresectable or Metastatic Melanoma
Adjuvant checkpoint inhibitor therapy is the standard of care for resectable melanoma. Although many patients derive lasting benefit from the treatment, a substantial number experience disease recurrence.