FDA Grants RMAT Designation to Novel TIL Therapy OBX-115 in Melanoma
Source: Targeted Oncology, September 2024
This designation follows the fast track designation that was granted to OBX-115 for the same indication in July 2024.
- The FDA has granted a regenerative medicine advanced therapy (RMAT) designation to OBX-115 for the treatment of patients with unresectable or metastatic melanoma that has been resistant to immune checkpoint inhibitor (ICI) therapy.
- OBX-115 is a novel tumor-infiltrating lymphocyte (TIL) therapy.
- In July 2024, the FDA granted the agent fast track designation.
OBX-115, a novel TIL therapy, has been granted FDA RMAT designation in unresectable or metastatic melanoma resistant to ICI therapy.