FDA introduced the Rare Disease Evidence Principles to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect.
At the 2026 Annual Meeting of the American Society of Clinical Oncology in Chicago, results from the phase III HARMONi-6 trial were presented at the plenary session and published simultaneously in The Lancet. The HARMONi-6 trial tested a novel bispecific antibody that engages PD-1 and VEGF (ivonescimab), given with platinum-doublet chemotherapy to patients with previously untreated advanced squamous non-small cell lung cancer.
