As part of the ANDA pathway, Bravnetsa is the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to the reference product, Lutathera.
ASTRO’s first standalone clinical practice guideline for bladder cancer recommends trimodal therapy vs radical cystectomy for select muscle-invasive disease cases.
The interim 3-year OS rates were 71.2% with OST-HER2 vs 45.8% in historical controls in a phase 2b trial of fully resected, pulmonary metastatic osteosarcoma.