FDA approval of the first cellular therapy for a solid (non-hematologic) cancer

The first US Food and Drug Administration-approved cellular therapy for treating a solid (non-hematologic) malignancy was granted accelerated approval on February 16, 2024.1 The therapy, lifileucel (Amtagvi), is manufactured by Iovance Biotherapeutics.1 Approval was for adult patients with unresectable or metastatic melanoma that was previously treated with standard therapies, and approval was based on results showing an overall response rate of 31.5% (95% confidence interval: 21.1%, 43.4%).1 The median duration of responses was not reached.