IOVA - A Close Look At Iovance Biotherapeutics' Accelerated Approval
2024-02-23 00:04:26 ET
Summary
- On February 16, the Food and Drug Administration granted an accelerated approval to Iovance Biotherapeutics' lifileucel or Amtagvi.
- This accelerated approval would make Amtagvi the first T-cell therapy for treating a solid tumor.
- I take a close look at the accelerated approval, the data, and share my thoughts here.
On February 16, 2024, the Food and Drug Administration granted an accelerated approval to Iovance Biotherapeutics' ( IOVA ) lifileucel or Amtagvi, "a tumor-derived autologous T cell immunotherapy, for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor".
This accelerated approval would make Amtagvi the first T-cell therapy for treating a solid tumor [vs. approved CAR-T therapies for blood cancers]....
A Close Look At Iovance Biotherapeutics' Accelerated Approval