Results of the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial highlight the safety and effectiveness findings of Lumicell’s pivotal trial of its investigational Lumicell Direct Visualization System to identify residual breast cancer following removal of the primary specimen during initial lumpectomy.
Last week, FDA granted accelerated approval to Replimune Group Inc. for it’s biologic, RP1 (vusolimogene oderparepvec), following the FDA Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.
