The Cellular, Tissue, and Gene Therapies Advisory Committee will review Replimune’s twice-rejected BLA for RP1 plus nivolumab in advanced melanoma.
News|Videos|June 17, 2024
Phase 3 Study (PIVOTAL) of Neoadjuvant Intralesional Daromun vs. Immediate Surgery in Fully Resectable Melanoma With Regional Skin and/or Nodal Metastases
PIVOTAL (NCT02938299) is an open label, randomized, multicenter, phase 3 trial evaluating Daromun as a neoadjuvant intralesional therapy for resectable, locally advanced Stage III melanoma.
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The FDA issued final guidances on performance status, washout periods, and laboratory values aimed at expanding oncology trial participation.
PRAME-directed therapies represent a novel approach in the treatment of advanced melanoma.
A research team from Huntsman Cancer Institute at the University of Utah showed a pathway-targeted therapy that could be an effective melanoma treatment.
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