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.
Publications
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 Agrees to Review Opdivo for Post-Surgical Melanoma Treatment
The Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application to treat Opdivo (nivolumab) in patients with stage 2B or 2C melanoma that has been completely resected (surgically removed), according to Bristol Myers Squibb, the manufacturer of the immunotherapy agent.