OBX-115
- Generic Name
- OBX-115
FDA's July Roundup: Approvals, Fast Tracks, and Designations in Oncology
• The FDA approved FoundationOne Liquid CDx as a companion diagnostic for niraparib and abiraterone in BRCA-mutated metastatic castration-resistant prostate cancer.
• Several therapies received fast track designations, including OBX-115 for advanced melanoma and ADI-270 for metastatic clear cell renal cell carcinoma.
• Biologics license applications were accepted for remestemcel-L in pediatric steroid-refractory acute graft-vs-host disease and tabelecleucel for Epstein-Barr virus-positive posttransplant lymphoproliferative disease.
• The Oncologic Drugs Advisory Committee voted to require comprehensive phase assessments for new trial designs in perioperative regimens for non-small cell lung cancer.
Drug Development Updates
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