The FDA has accepted the supplemental biologics license application for nivolumab (Opdivo) as an adjuvant treatment for patients with completely resected stage IIB or IIC melanoma.
Regulatory
FDA Accepts Supplemental BLA For Nivolumab For Melanoma
The FDA has accepted the supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) as adjuvant monotherapy for patients with completely resected stage IIB or IIC melanoma, according to a Bristol Myers Squibb press release.1 The PDUFA date for this sBLA is October 13, 2023.
FDA Approval Sought for Lifileucel in Unresectable or Metastatic Melanoma
Iovance Biotherapeutics has submitted a rolling biologics license application (BLA) to the FDA seeking the approval of the tumor infiltrating lymphocyte (TIL) therapy lifileucel (LN-44) for the treatment of patients with advanced unresectable or metastatic melanoma who progressed on or after prior anti–PD-1/L1 therapy and targeted therapy.
FDA Greenlights BTD of a Personalized mRNA Vaccine for High-Risk Melanoma
Positive data from the phase 2b KEYNOTE-942 trial (NCT03897881) have led to the FDA to grant a breakthrough therapy designation to mRNA-4157/V940 in combination with pembrolizumab (Keytruda) for the adjuvant treatment of patients with high-risk melanoma following complete resection, according to Moderna, Inc.