The FDA accepted for review new drug applications that seek the use of the COMBO450 regimen to treat patients with BRAF-mutant advanced, unresectable or metastatic melanoma, according to the drugs’ manufacturer.
Regulatory
FDA Grants LN-144 Fast Track Status for Melanoma
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.
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.