The FDA has granted LN-144, an adoptive cell therapy that uses tumor-infiltrating lymphocyte (TIL) technology developed by Iovance Biotherapeutics, a fast track designation for the treatment of patients with advanced melanoma.
Regulatory
Ipilimumab Approved by FDA for Pediatric Melanoma
Ipilimumab (Yervoy) has been approved by the FDA for the treatment of patients aged greater than or equal to 12 years with unresectable or metastatic melanoma, according to Bristol-Myers Squibb (BMS), the manufacturer of the CTLA-4 inhibitor.
FDA grants orphan drug designation to pIL-12 for unresectable melanoma
The FDA granted orphan drug designation to tavokinogene telsaplasmid for the treatment of unresectable metastatic melanoma, according to the agent’s manufacturer.
FDA fast tracks ocular melanoma treatment
A new class of treatment that can selectively destroy cancer cells using a light-activated viral nanoparticle has received FDA fast track designation for the treatment of ocular melanoma.