How small biotech succeeded where Big Pharma failedJanuary 30, 2023 - "Italian drugmaker Menarini has succeeded where three European Big Pharmas have failed, pushing the first oral selective estrogen receptor degrader (SERD) to treat breast cancer across the FDA finish line." The approval for Orserdu is backed by results from a phase 3 trial of 478 patients that showed it reduced the risk of disease progression or death by 45% versus standard-of-care endocrine therapies in patients whose tumors had ESR1 mutations. The median progression-free survival was 8.6 months on Orserdu, versus 1.9 months for standard of care, in patients who had been treated with a CDK4/6i for at least 12 months, the companies said.
ESR1 mutations are present in up to 40% of ER+, HER2-advanced or mBC cancers and drive resistance to endocrine therapies,
https://www.fiercepharma.com/pharma/menarini-shows-big-pharmas-how-first-approval-oral-serd-breast-cancer