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.
Publications
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.
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.
FDA Grants Breakthrough Therapy Designation to mRNA-4157/V940 Plus Pembrolizumab in High-Risk Melanoma
The FDA has granted a breakthrough therapy designation to the investigational personalized mRNA cancer vaccine mRNA-4157/V940 in combination with pembrolizumab (Keytruda) for the adjuvant treatment of patients with high-risk melanoma following complete resection.