FDA Fast Track Designation for OBX-115 for the Treatment of Advanced Melanoma
“FDA Fast Track Designation underscores the ongoing unmet need for patients with melanoma that has progressed on or after ICI therapy, agnostic of mutational status, and that OBX-115 may have the potential to address that unmet need,” said Madan Jagasia, M.D., Chief Executive Officer of Obsidian. “OBX-115 is poised to be a transformative treatment option due to its patient-centric focus, including compatibility with core needle biopsy tumor tissue procurement and positively differentiated safety and tolerability profile relative to non-engineered TIL cell therapy. We are highly encouraged by the most recent safety and efficacy data presented at the 2024 American Society of Clinical Oncology Meeting. With this designation, we look forward to continued collaborative interaction with the FDA as we advance OBX-115 clinical development in the broad post-ICI setting.”
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